Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Carcinoma

Adenocarcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Adenocarcinoma of Lung

Adenocarcinoma, Bronchiolo-Alveolar

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Adenocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Satraplatin

Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.

PURPOSE: This trial is designed to compare the combination of the investigational oral cytotoxic drug, satraplatin, and radiation therapy for patients with locally advanced Non-Small Cell Lung Cancer (NSCLC) with no prior chemotherapy or radiation therapy treatment. Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria.

WHAT IS SATRAPLATIN: Satraplatin is an oral, investigational anticancer drug that is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.

RATIONALE: Intravenously administered platinum-based drugs are currently used in combination with radiation therapy in the treatment of patients with locally advanced NSCLC. The purpose of this Phase I trial is to determine a tolerable dose and schedule for the oral platinum drug (satraplatin) when given to NSCLC patients throughout the course of their radiotherapy treatment.

Satraplatin for Locally Advanced Non-Small Cell Lung Cancer With Simultaneous Radiotherapy

A Phase 1/2 Study With Satraplatin and Simultaneous Radiation in Locally Advanced Non-Small Cell Lung Cancer

Agennix

Amino Acids

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Satraplatin administered orally once daily for 5 consecutive days followed by erlotinib for 14 consecutive days

Erlotinib administered orally once daily. Erlotinib - \[6,7-Bis(2-methoxy-ethoxy)-quinazolin-4-y\]- (3-ethynyl-phenyl)amine hydrochloride, molecular weight 393.4. This is a small molecule that competes with the binding of ATP to the intracellular tyrosine kinase domain of EGFR, thereby inhibiting receptor autophosphorylation and blocking downstream signal transduction.

Erlotinib

satraplatin 100 mg/m2 orally once daily for 5 consecutive days (days 1-5)followed by erlotinib 150mg/day for 14 consecutive days (days 8-21).

Satraplatin JM-216, bis-aceto-ammine dischlorocyclohexylamine platinum)is a third-generation platinum analogue with activity following oral administration. The molecular formula for satraplatin is C10H22N2Cl2O4Pt, which is structured as an octahedral platinum compound.

Corey Langer, MD

Patients ≥ 70 years of age with locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) frequently do not receive systemic cytotoxic chemotherapy due to concerns regarding their inability to tolerate treatment. Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are agents with favorable toxicity profiles that have shown activity in patients with NSCLC. Erlotinib as a single-agent is currently approved for the treatment of patients with NSCLC whose disease has progressed following one prior course of chemotherapy and is currently being evaluated in NSCLC patients who have not received prior systemic treatment. However, when studied with combination chemotherapy in the first-line setting, continuous daily administration of erlotinib did not result in improved patient survival. Further clinical and in vitro data suggest that the sequencing of cytotoxic chemotherapy with EGFR TKIs is important to maximize their therapeutic potential when administered in combination.

Satraplatin is an oral, investigational anticancer drug that is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally and is currently being evaluated in a pivotal phase 3 clinical trial as 2nd-line therapy for patients with hormone refractory prostate cancer.

The rationale for this study is to develop an active and well-tolerated oral regimen for patients ≥ 70 years of age with NSCLC. Administration of the study drugs will be sequenced with satraplatin administered on days 1-5 and erlotinib on days 8-21 of each 28-day cycle. The primary endpoint will be progression-free survival (PFS). Patients will be randomized to treatment with either the experimental regimen or single-agent continuous erlotinib.

Erlotinib as a single-agent is currently approved for the treatment of patients with NSCLC whose disease has progressed following one prior course of chemotherapy and is currently being evaluated in NSCLC patients who have not received prior systemic treatment. However, when studied with combination chemotherapy in the first-line setting, continuous daily administration of erlotinib did not result in improved patient survival. Further clinical and in vitro data suggest that the sequencing of cytotoxic chemotherapy with EGFR TKIs is important to maximize their therapeutic potential when administered in combination.

Satraplatin is an orally administered platinum analogue that has shown promising single-agent activity in multiple tumor types including prostate, ovarian, and small cell lung cancer. Additionally, the single-agent activity of satraplatin in NSCLC is similar to that of other commonly used platinum agents used to treat NSCLC. However, satraplatin is better tolerated than cisplatin, causing less renal toxicity and ototoxicity, and it can be administered in the outpatient setting. From a toxicity profile, it is more similar to carboplatin in that myelosuppression is its dose limiting toxicity (DLT). Satraplatin is currently being evaluated in a pivotal phase 3 clinical trial as 2nd-line therapy for patients with hormone refractory prostate cancer.

The rationale for this study is to develop an active and well-tolerated oral regimen for patients ≥ 70 years of age with NSCLC who may not be candidates for aggressive combination systemic chemotherapy. Administration of the study drugs will be sequenced with satraplatin administered on days 1-5 and erlotinib on days 8-21 of each 28-day cycle. As erlotinib has shown an advantage in survival without a commensurate improvement in response rate, the primary endpoint will be progression-free survival (PFS); thus patients will be randomized to treatment with either the experimental regimen or single-agent continuous erlotinib.

A Study Comparing Sequential Satraplatin & Erlotinib to Erlotinib in Unresectable Stage 3/4 Non-small-cell Lung Cancer (NSCLC)

A Phase 2 Study Comparing Sequential Satraplatin and Erlotinib to Single-Agent Erlotinib in Patients ≥ 70 Years of Age With Unresectable Stage 3 OR 4 Non-Small Cell Lung Cancer as 1st-Line Therapy

Docetaxel

Tubulin Modulators

Antimitotic Agents

Satraplatin - oral administration within 2 hours of docetaxel infusion. Subsequent dosing will be on days 2-5 at approximate 24 hour intervals.

Docetaxel will be administered as intravenous infusion over 1 hour followed by saline flush.

satraplatin and docetaxel

George Wilding, MD

This is a single center, open-label, non-randomized, Phase I dose finding study of the investigational, oral cytotoxic drug, satraplatin (JM-216), in combination with docetaxel in patients with advanced solid tumors for whom curative therapy is not available. Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria.

PURPOSE: The purpose of this trial is to determine a tolerable dose and schedule for the combination of satraplatin and docetaxel when given to patients with advanced solid tumors.

WHAT IS SATRAPLATIN: Satraplatin is an oral, investigational anticancer drug that is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.

Study of Satraplatin (JM-216) in Combination With Docetaxel

Phase I Study of the Oral Platinum Agent Satraplatin (JM-216) in Combination With Docetaxel in Treatment of Advanced Malignancies

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Anti-Inflammatory Agents

Androgens

Prednisone

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

satraplatin - 80 mg/m\^2 days 1-5 of every 35 day cycle prednisone - 5 mg twice daily every 35 days

80 mg/m\^2 days 1-5 of every 35 day cycle

prednisone

William L Dahut, M.D.

Background:

Satraplatin is an experimental drug that may be of benefit to patients with prostate cancer.

Prednisone is approved for treating prostate cancer.

The gene excision repair cross-complementing rodent repair deficiency complementation group 1 (ERCC1) helps repair cell damage caused by satraplatin. It is possible that patients who have a variant of this gene will not benefit from treatment with satraplatin because the drug will not be able to damage the cancer cells effectively.

Objectives:

To determine if satraplatin may help treat prostate cancer in patients with certain variants of the ERCC1 gene.

Eligibility:

Patients with advanced androgen-independent prostate cancer whose disease has not responded to hormonal therapy or at least one type of chemotherapy and whose x-rays, scans or other tests have shown their cancer to be spreading.

Design:

Participants have a blood test to determine if they have a variant of the ERCC1 gene.

Participants take satraplatin by mouth every day for 5 consecutive days out of every 35 days and prednisone by mouth every day. These 35-day treatment cycles may continue for 6 months or longer, depending on the benefits and side effects of the treatment.

During the treatment period, patients undergo the following tests and procedures:

* Blood tests on days 1 of the treatment cycle.
* Weekly blood draws for the first 3 treatment cycles.
* Imaging studies (e.g., bone scans, computed tomography (CT) scans) every two cycles to determine the response to treatment.
* Surgical or medical suppression of testosterone in patients whose cancer cells continue to grow due to exposure to the hormone....

Background:

* Satraplatin is an oral, third-generation platinum analog that has recently been shown to increase prostatic specific antigen (PSA) decline rates and progression-free survival in hormone-resistant prostate cancer.
* Satraplatin acts by binding to deoxyribonucleic acid (DNA) forming intra- and interstrand cross links (DNA adducts), resulting in cell-cycle arrest in G2 phase and eventual apoptosis. One of the mechanisms that bring about resistance to platinum-based chemotherapy is removal of the platinum-DNA adducts by DNA repair pathways, called nucleotide excision repair (NER) and base excision repair (BER) pathways.
* Polymorphisms in the DNA repair genes causing impaired NER and BER capability has recently been shown in some cancers, including head and neck squamous cell carcinoma, non-small cell lung carcinoma, and ovarian carcinoma to predict better treatment outcome and response to platinum treatment.

Objectives:

* Primary objective of this single arm study is to determine if the presence of ERCC1 variant gene polymorphism which is involved with DNA damage repair may be associated with an impact on the progression-free survival of patients with metastatic prostate cancer.
* Secondary objectives of this study includes demonstration of biologic effect by the drug satraplatin in the patient and in the tumor whenever possible, by obtaining tissue biopsy and white blood cell collections, to determine correlation of biologic or clinical effects with PSA progression, evaluate correlations between genotype expression, repair pathways and clinical events, and obtain laboratory correlates which will include pharmacogenetic analysis of prostate cancer patients with genotyping using Polymerase chain reaction (PCR) followed by either restriction fragment length polymorphism or direct sequencing to genotype single nucleotide polymorphisms of ERCC1, x-ray repair cross-complementing protein 1 (XRCC1), and poly (ADP-ribose) polymerase 1 (PARP1).

Eligibility:

* Patients with metastatic androgen-independent prostate cancer.
* Had docetaxel-based chemotherapy, but no more than 1 previous cytotoxic chemotherapy line.
* Good organ function.

Design:

* Phase II trial with single stage design and a planned accrual of 66 patients.
* Progression-free survival will be determined using a Fisher's exact test.
* Will treat all enrolled patients with oral satraplatin 80 mg/m\^2 dose on days 1-5 of every 35-days cycle plus Prednisone 5 mg twice daily every 35 days.
* Genotyping will be performed after the first 20 patients to determine if the proportion for wild-type ERCC1 and variants follow a 20:80 split.

Satraplatin and Prednisone to Treat Prostate Cancer

A Phase II Study of Satraplatin and Prednisone in Metastatic Androgen Independent Prostate Cancer (AIPC)

Time between the start of therapy and progression. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive Disease is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Overall Survival is the time between the first day of treatment to the day of death.

National Cancer Institute (NCI)

Principal investigator

The time frame for adverse events includes one year follow-up data.

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. William Dahut

24 pts were enrolled but only 21/24 were assessed for OS. One pt died on treatment and (e.g.3 pts were non-evaluable for analysis of response).

Progression Free Survival.

Number of Participants With Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0)

Median Overall Survival (OS)

Overall Study

Paclitaxel

Albumin-Bound Paclitaxel

Satraplatin and abraxane will be given in escalating cohorts on a 3 + 3 design from satraplatin 40mg/m2 and abraxane 80mg/m2

Dose escalation of 40, 60 and 80 mg/m²/day on days 1-5

Dose escalation of 80 and 100 mg/mm²/day on days 1,8,15,22 every 28 days

Abraxane

Hari Deshpande, M.D.

This is a phase I dose escalating study of oral satraplatin in combination with Abraxane administered weekly for three out of every four weeks in patients with advanced solid cancers.

Phase I Study of the Combination of Satraplatin and Abraxane in Advanced Cancers

Phase I Dose Finding Study of the Orally Bioavailable Platinum Analog Satraplatin in Combination With Abraxane (Paclitaxel Protein-bound Particles) in Advanced Cancers

Yale University

Assistant Professor of Medicine

PURPOSE:

The SPARC trial is designed to compare the combination of the investigational oral cytotoxic drug, satraplatin, and prednisone, versus prednisone alone as second line chemotherapy in patients with hormone-refractory prostate cancer (HRPC).

TARGET PATIENT POPULATION:

The SPARC trial is intended for patients who have hormone-refractory prostate cancer (HRPC) and whose disease has progressed after treatment with one chemotherapy regimen. Please refer to the Eligibility Criteria page for the key inclusion and exclusion criteria.

WHAT IS SATRAPLATIN:

Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally. Satraplatin is also the only platinum-based drug that has demonstrated efficacy against prostate cancer in a randomized trial.

RATIONALE:

There are currently no approved chemotherapy drugs for the second line treatment of hormone-refractory prostate cancer (HRPC). In a preliminary randomized trial conducted in Europe, the combination of satraplatin and prednisone had superior activity compared to prednisone alone, for the treatment of HRPC patients who had not previously been treated with chemotherapy

Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen

A Multi-National Phase III Study of Satraplatin Plus Prednisone or Placebo Plus Prednisone in Patients With Hormone Refractory Prostate Cancer Previously Treated With One Cytotoxic Chemotherapy Regimen

Symptoms and General Pathology

Neoplasm Metastasis

Analgesics

Mitoxantrone

Preoperative chemotherapy using Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin (CDMS) as a single agent performed 45 days before surgery：Cabazitaxel 25 mg/m2, Docetaxel 35 mg/m2, Mitoxantrone 4 mg/m2 or Satraplatin 80 mg/m2, through intravenous (IV) or oral (Satraplatin) administration. IV or oral administration once every 7 days, totally 4 cycles. There is a 17-day interval between the last dose and surgery.

Procedure: radical prostatectomy surgery.

No neoadjuvant chemotherapy using CDMS will be done for patients who are diagnosed with localized prostate cancer but subject to direct surgery to radically remove the primary tumor.

As preoperative neoadjuvant chemotherapy, drugss including Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin (CDMS) will be administered as a single agent performed 45 days before surgery：Cabazitaxel 25 mg/m2, Docetaxel 35 mg/m2, Mitoxantrone 4 mg/m2 or Satraplatin 80 mg/m2, through intravenous (IV) or oral (Satraplatin) administration. IV or oral administration once every 7 days, totally 4 cycles. There is a 17-day interval between the last dose and surgery.

Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin

Yu Sun, Ph.D

Weijun Ma, Ph.D

Jiannan Chen, Ph.D

Qilai Long, Ph.D

Current agents administered in therapeutic regimens of prostate cancer employ different mechanisms to eliminate neoplastic cells by inducing substantial apoptosis and causing tumor regression. Treatment with neoadjuvant chemotherapy before radical prostatectomy may better control the tumor before it has the chance to convert into the disease of castration-resistant prostate cancer (CRPC), which is finally refractory to most modalities of clinical intervention with a clinically lethal nature.

Prostate cancer is the development of neoplasia in the prostate, a major gland in the male reproductive system. While most prostate cancers grow slowly, some can develop relatively quickly and aggressively. In a later stage of the disease, cancer cells may disseminate from the prostate to other organs of the body, particularly the bone, lung, brain and lymph node. Prostate cancer initially cause no symptoms, but in an advanced stage it can cause difficulty in urinating, blood in the urine, or pain in the pelvis. A non-malignant or precursor form of prostate cancer known as benign prostatic hyperplasia may produce similar symptoms, although it is essentially not invasive.

Many prostate cancer patients can be safely followed with active surveillance or watchful actions. However, the major forms of clinical treatments include a combination of surgery, radiation, hormone therapy or chemotherapy. If it only occurs inside the prostate, the disease is generally curable. However, when cancer cells have spread to the bones, cytotoxic or harsh therapies are necessary. Outcomes depend on a person's age and other health conditions as well as how aggressive and extensive the cancer is. Most people with prostate cancer do not end up dying from the disease, and the 5-year survival rate in the United States is approximately 99%. To date, it is the 2nd most common type of malignancy and the 5th leading cause of cancer-related death in men. In 2012 it affected 1.1 million men and claimed 307,000 deaths. Prostate cancer occur more frequently in the western countries or developed world, but incidence rates have been continuously arising in the developing countries. Clinical detection increased significantly in the 1980s and 1990s in the global range due to development of the gold standard--PSA testing. Studies of males who died from unrelated causes have found prostate cancer in 30% to 70% of those over the age of 60.

Most hormone-naive prostate cancers become resistant to treatments after 1-3 years and resume growth despite hormone therapy, a condition termed as "hormone-refractory prostate cancer" (HRPC) or "castration-resistant prostate cancer (CRPC)". The most prevalent chemotherapeutic agent docetaxel (Taxotere) has been used as a standardized modality for CRPC and provides a median survival benefit of 2-3 months. A second-line chemotherapy involves cabazitaxel. Although combination of bevacizumab, docetaxel, thalidomide and prednisone appears effective in the treatment of CRPC, these agents are usually used after the occurrence of CRPC, not before. Thus, whether or not these patients should receive chemotherapy prior to development of CRPC, and whether this approach can prevent the aggressive progression of the disease to a treatment refractory status, remain largely open but intriguing questions.

In this study, investigators performed a Phase I, single agent exploration, multicenter clinical trial to establish the treatment efficacy of several chemotherapeutic agents in patients with high risk localized prostate cancer who have developed the primary cancer in prostate. Up to 5 cohorts have been enrolled to determine the effectiveness and safety of single therapeutic strategy. Besides the five-year disease-free survival, overall survival and five-year metastasis-free survival post treatment, investigators also take into account the anticancer agent-induced tumor stroma damage extent, which may provide further evidence to support the treatment efficacy and assess the potential influence of a damaged tumor microenvironment on disease progression or regression in clinical settings.

Chemotherapy (single agent of CDMS) will be performed 45 days before surgery for patients who are diagnosed with prostate cancer without distant metastasis. The chemotherapy using CDMS will done for 4 cycles within 30 days after first diagnosis of prostate cancer.

Both the participants and care providers will be blind to the agents, but the investigators will be aware of and keep track of the whole regime and agents.

All participant patients should be male, adult.

A Randomised Trial of Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin (CDMS) Plus Surgery for Prostate Cancer Patients Without Metastasis

A Phase I Study of Neoadjuvant Chemotherapy Involving Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin (CDMS) Followed by Surgery for Patients With High Risk Localized Prostate Cancer

Investigators are happy to make individual participant data (IPD) available to other researchers upon request, as long as the data are not confidential and not restrained by the ethics policy.

There is no disease-associated progression during the 5 years post treatment (chemotherapy plus surgery).

The overall survival status and distant metastasis-free survival status during the 5 years post treatment (chemotherapy plus surgery).

Fudan University

Qilu Hospital of Shandong University

Shanghai Jiao Tong University School of Medicine

Professor

Recurrence

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)

Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days

10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)

bevacizumab

80 mg/m(2), Orally, Days 1-5, every 35 days

satraplatin

Ulka N. Vaishampayan, MD

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as satraplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving satraplatin together with bevacizumab may kill more tumor cells.

PURPOSE: This clinical trial is studying how well giving satraplatin together with bevacizumab works in treating patients with metastatic prostate cancer previously treated with docetaxel.

OBJECTIVES:

Primary

* Determine the time to progression in patients with metastatic androgen-independent prostate cancer previously treated with docetaxel currently treated with satraplatin and bevacizumab.

Secondary

* Determine the toxicity of this regimen in these patients.
* Assess the prostate-specific antigen (PSA) response rate in patients treated with this regimen.
* Determine the overall survival of patients treated with this regimen.
* Assess changes in levels of N-terminal collagen peptide (NTX) and bone-specific alkaline phosphatase (BSAP) in patients treated with this regimen.
* Correlate urine NTX and serum BSAP levels with time to progression in patients treated with this regimen.

OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral satraplatin on days 1-5. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 28-42 days.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Satraplatin and Bevacizumab in Treating Patients With Metastatic Prostate Cancer Previously Treated With Docetaxel

Phase II Trial of Bevacizumab and Satraplatin in Docetaxel Treated Metastatic Androgen Independent Prostate Cancer

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. TTP is measured using Kaplan-Meier product-limit.

Toxicity was categorized according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (version 3.0).

Prostate-specific antigen (PSA) response rate as measured by a 50% or better decrease in PSA levels

Overall survival using the Kaplan-Meier method

Barbara Ann Karmanos Cancer Institute

Principal Investigator

Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)

Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days

bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)

satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days

Bevacizumab and Satraplatin

Small sample size, correlative ERCC testing conducted in only a subset of patients (14 of 30 pts) and the findings of this study are hypothesis generating however validation in larger sample size would be needed.

Ulka Vaishampayan, M.D.

Bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) Bevacizumab: 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)

Satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days

Time to Progression

Nausea

Vomiting

Diarrhea

Leukopenia

Neutropenia

Anemia

Edema

Dehydration

Hyperglycemia

Thrombocytopenia

Proteinuria

Hypertension

Fatigue

Hypokalemia

Hyponatremia

hypomagnesemia

Creatinine

Constipation

Bloating/Distention

Fever/Rigors

Dyspepsia

Weight Loss

Anorexia

Allergic Reaction

Toxicity, Presented as the Number of Participants With Adverse Events

Percentage of Participants With Prostate-specific Antigen (PSA) Response

Overall Survival

Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days

William K Oh, M.D.

The purpose of the study is to test genes for BRCAness(BRCA\[BReast CAncer\] gene) Studying these genes could help predict which patients would benefit from treatment with satraplatin, a medication being used for subjects who have failed prior chemotherapy. All subjects will have a biopsy of metastatic lesions to measure BRCAness (a gene signature). This gene signature may be able to predict response to satraplatin and a tool will be developed to be able to screen patients likely to benefit from satraplatin. Subjects will all receive Satraplatin days 1-5 and Prednisone 5 mg twice daily every 35 days. Response rates will be evaluated every 2 cycles or approximately every 9 weeks. Patients will be considered responders if they have measurable disease meeting criteria for partial or complete response. PSA will be measured day one of each treatment cycle. Each treatment cycle is 35 days.

We will be developing a genomic based signature of "BRCAness" based on literature of genomic signatures from women with breast cancer and germline BRCA mutations.The "BRCAness" breast cancer signature will differentiate germline BRCA 1/2 breast cancers from standard estrogen-receptor (+) breast cancers. We will obtain a library of genomic signatures Recently these techniques have been used to develop a transcriptional "signature" for androgen receptor (AR) activity in men with CRPC(Castration Resistant Prostate Cancer). The investigator will apply the "BRCAness" breast cancer signature to pathological prostate cancer specimens to determine the percentage of patients in the overall prostate cancer population that express this signature, as well as the clinical and histological phenotype of this population.

This novel prostate cancer "BRCAness" signature will be developed over a period of 4-6 months. This "BRCAness" signature has not previously been evaluated in prostate cancer patients and would be expected, based on known characteristics of BRCA mutant breast and ovarian cancers, to be more platinum-responsive. Relevant clinical data, including histology, grade, stage, size of residual tumor, recurrence, and survival, will be obtained from outpatient and inpatient charts to perform subsequent correlative studies.

All patients enrolled in the phase II clinical trial with satraplatin will have pre-treatment biopsies of metastatic sites. All of the specimens will be frozen, batched and stored as previously described. We anticipate that all patients will be enrolled 16 months from when the trial opens. When the last patient is enrolled in the trial and all of the metastatic biopsies have been collected, they will be shipped in bulk on dry ice to laboratory for RNA(ribonucleic acid) isolation, RNA quality assessment and processing, microarray hybridization, microarray data quality assessment, and "BRCAness" prostate cancer signature application. Frozen biopsies will be processed for microarray analysis using laser capture microdissection and RNA amplification using adaptations of previously published methods. The application of the prostate cancer BRCAness signature will take place over two months.

Utilizing A Genomic Sig for "BRCAness" to Eval the Efficacy of Satraplatin in Men With Met. Castration Resistant Prostate Ca

Predicting Response to Platinum Chemotherapy in Metastatic Castration Resistant Prostate Ca(mCRPC)Using a Genomic Signature for "BRCAness": A Phase II Prospective Open Label Clinical Trial of Satraplatin in Men With mCRPC Who Have Progressed on Docetaxel

Patients with good tolerance of treatment who have a 30% PSA decline from their pre-treatment level within 3 months of treatment initiation will be considered responders provided objective tumor measurements are stable or also demonstrate response.

Response rate - Maximum decline in PSA that occurs during treatment.

Progression Free Survival is measured from the time of the initiation of therapy until the first date that recurrent or progressive disease is objectively documented. Progression is a composite endpoint that can be based upon PSA, objective measures of disease, symptoms or death. Time to disease progression.

Patients followed for a minimum of 24 months or until death. Patients and/or their family members will be contacted via telephone calls or certified letter.

Prostate Cancer Foundation

William K. Oh

Chief, Division of Hematology/Medical Oncology

Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Satraplatin for Locally Advanced Non-Small Cell Lung Cancer With Simultaneous Radiotherapy	NCT00093132	Carcinoma, Non-... Lung Cancer	Satraplatin	18 Years -	Agennix
A Study Comparing Sequential Satraplatin & Erlotinib to Erlotinib in Unresectable Stage 3/4 Non-small-cell Lung Cancer (NSCLC)	NCT00370383	Lung Cancer	Erlotinib Satraplatin	70 Years -	Agennix
Study of Satraplatin (JM-216) in Combination With Docetaxel	NCT00125411	Tumors	satraplatin and...	18 Years -	Agennix
A Study Comparing Sequential Satraplatin & Erlotinib to Erlotinib in Unresectable Stage 3/4 Non-small-cell Lung Cancer (NSCLC)	NCT00370383	Lung Cancer	Erlotinib Satraplatin	70 Years -	Agennix
Satraplatin and Prednisone to Treat Prostate Cancer	NCT00634647	Prostate Cancer Genetic Polymor...	Satraplatin prednisone	18 Years -	National Institutes of Health Clinical Center (CC)
Phase I Study of the Combination of Satraplatin and Abraxane in Advanced Cancers	NCT00473720	Advanced Cancer...	Satraplatin Abraxane	18 Years -	Yale University
Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen	NCT00069745	Prostate Cancer Hormone Refract...	Satraplatin Prednisone	18 Years -	Agennix
A Randomised Trial of Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin (CDMS) Plus Surgery for Prostate Cancer Patients Without Metastasis	NCT03258320	Prostate Cancer...	Cabazitaxel, Do...	40 Years - 75 Years	Shanghai Jiao Tong University School of Medicine
Satraplatin and Bevacizumab in Treating Patients With Metastatic Prostate Cancer Previously Treated With Docetaxel	NCT00499694	Prostate Cancer	bevacizumab satraplatin	18 Years - 120 Years	Barbara Ann Karmanos Cancer Institute
Utilizing A Genomic Sig for "BRCAness" to Eval the Efficacy of Satraplatin in Men With Met. Castration Resistant Prostate Ca	NCT01289067	Prostate Cancer	Satraplatin	18 Years -	Icahn School of Medicine at Mount Sinai
Utilizing A Genomic Sig for "BRCAness" to Eval the Efficacy of Satraplatin in Men With Met. Castration Resistant Prostate Ca	NCT01289067	Prostate Cancer	Satraplatin	18 Years -	Icahn School of Medicine at Mount Sinai
A Phase I Study of the Oral Platinum Agent Satraplatin in Combination With Weekly Docetaxel	NCT00313456	Tumors Prostate Cancer	Satraplatin	18 Years -	Agennix

Spots Global Cancer Trial Database for satraplatin

Every month we try and update this database with for satraplatin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for satraplatin

Every month we try and update this database with for satraplatin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for satraplatin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.