Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antineoplastic Agents

Androgens

Doxorubicin

Liposomal doxorubicin

Docetaxel

Tubulin Modulators

Antimitotic Agents

Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.

Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.

Taxotere

Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.

Doxil

Damian Laber, MD

This clinical research study is being done because there is no effective treatment for advanced androgen-independent prostate cancer. This study will determine if the combination of medications (Taxotere and Doxil) are effective in this kind of cancer.

Each cycle of treatment will consist of four weeks. The 2 types of medicines are given intravenously (in a vein). Doxil is given on the first day of each cycle. Taxotere is given once a week for the first 3 weeks of each cycle. This is followed by a week of rest until the next cycle starts. Treatment is given on an outpatient basis and hospitalization is not anticipated.

Prior to entry on this study, "screening" tests are performed to determine eligibility to participate. This will involve a complete history and physical examination, vital signs, pain assessment, blood tests including CBC (complete blood count), serum chemistry, and PSA (prostate specific antigen), x-rays (chest x-ray, possible plain films of bones if there are abnormal findings on bone scan for clarification), computerized tomography (CT) scans of the abdomen and pelvis, bone scans, a MUGA scan or 2-D echocardiogram, and a quality of life questionnaire.

After treatment starts the following tests are done to regularly monitor for beneficial and toxic effect of the treatment:

Every week: blood tests.

Every month: physical examination, weight, vital signs (blood pressure, respiration, temperature and heart rate) and PSA test.

Every 2 months: pain assessment, quality of life questionnaire, x-rays (chest x-ray and possible pain films of bones if positive findings are seen on bone scan), computerized tomography (CT) scans (abdomen and pelvis) and bone scans.

Participants may continue with any procedures that are part of their regular cancer care. It is anticipated that participants will be in the study for a minimum of 2 months and as long as they are benefiting from the treatment.

Study of Taxotere and Doxil to Treat Advanced Androgen-Independent Prostate Cancer

Phase I/II Study of Docetaxel (Taxotere) in Combination With Doxorubicin HCI Liposome Injection (Doxil) in Advanced Androgen-Independent Prostate Cancer (AIPC)

James Graham Brown Cancer Center

University of Louisville

Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.

Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.

Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.

Taxotere and Doxil

>=18

Age, Customized

Sex: Female, Male

University of Louisville, James Graham Brown Cancer Center Clinical Trials

Study was terminated and PI has left the institution. Sincere efforts were made to gather and report the data, however, no data is available for the study

Maximum Tolerated Dose and Toxicity Profile

There is no data to report. Data for this trial was not analyzed, the PI left institution.

Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.

Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.

Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.

There is no data to report. Data for this trial was

There is no data to report. Data for this trial was not analyzed, the PI left institution.

Response Rate

Overall Study

Anti-Infective Agents

Thalidomide

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg

On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days

Gurkamal S Chatta, MD

The primary objective of this study is to evaluate PSA response rates of the combination of Doxil and Thalidomide in patients with AIPC who have failed chemotherapy. Secondary objectives include: 1) To evaluate the clinical response rate of this combination on measurable disease 2) To evaluate overall survival for this combination.

This is an open label, Phase II trial of thalidomide and Doxil in patients with androgen independent prostate cancer whom have a rising PSA while on chemotherapy. The primary objective of this study is to evaluate PSA response rates of the combination of Doxil and Thalidomide in patients with AIPC who have failed chemotherapy. Secondary objectives include: 1) To evaluate the clinical response rate of this combination on measurable disease (If measurable soft tissue lesions are present on radiological or clinical exam) ; 2) To evaluate overall survival for this combination. There will be between 18 and 35 subjects at least 18 years of age enrolled on this single site study.

Thalidomide and Doxil® in Patients With Androgen Independent Prostate Cancer (AIPC)

Phase II Trial of Thalidomide and Doxil® (Doxorubicin HCL Liposome Injection) in Patients With Androgen Independent Prostate Cancer (AIPC) With a Rising PSA While on Chemotherapy

The number of patients experiencing a response to treatment, per RECIST criteria / total number of patients evaluable for response.

PSA response as stable disease or progressive disease, per Prostate-Specific Antigen Working Group criteria.

Time from start of treatment until the disease progression per RECIST criteria.

Ortho Biotech, Inc.

University of Pittsburgh

Combination of Thalidomide and Doxil

Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg

Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days

Thalidomide and Doxil

Age, Continuous

Rita Johnson RN BSN CCRC

Patients that received greater than one cycle of therapy.

Stable disease

Progressive Disesase

Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg

Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days

Patients that received greater than one cycle of therapy and met criteria for stable or progressive disease according to Prostate-Specific Antigen Working Group criteria.

Best Overall PSA Response

Overall Survival

Time to Progression

Sorafenib

Protein Kinase Inhibitors

Oral Single agent Sorafenib 400mg twice daily

Chadi Nabhan, MD

The primary objective of this study is to evaluate the safety of combining Sorafenib and chemotherapy (mitoxantrone or docetaxel) in patients with AIPC.

Patients who have AIPC and are progressing despite systemic chemotherapy will be offered participation in this study. Patients who relapse or progress shortly (within 12 weeks) after discontinuation of chemotherapy with either docetaxel/prednisone or mitoxantrone/prednisone will also be offered participation in this trial. Enrolled patients will receive sorafenib as per protocol define dose. Sorafenib will be administered in combination with the last chemotherapy utilized. If there is no disease progression after 6 cycles, chemotherapy will be stopped and Sorafenib may continue until disease progression.

Sorafenib to Overcome Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer

Phase I/II Study to Evaluate the Ability of Sorafenib in Overcoming Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer (AIPC)

The actual percentage was determined by taking the number of patients requiring a dose reduction divided by the total number of patients multiplied by100%

Assessment of response was done per Response Evaluation Criteria in Solid Tumors (RECIST) criteria as outlined in the protocol. Complete Response (CR) defined as disappearance of all measurable lesions. Partial Response (PR) more than 30% decrease in the sum of longest diameter of measurable lesions compared to baseline. Stable Disease (SD) lesions should have no sufficient decrease for PR any sufficient increase to meet criteria for PD. Progressive Disease (PD) more than 20% increase in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies or the appearance of 2 or more new bony lesions. For patient with measurable disease,prostate-specific antigen (PSA), progression in the absence of measurable disease progression will not be considered progressive disease. Overall Clinical Benefit (OCB) (CR + PR+ SD)/#participants.

PSA Biochemical Response = PSA complete response + PSA partial response. A PSA complete response is defined as a non-detectable PSA (\<4 ng/dl). A PSA partial response is defined as a PSA that decreases by greater than or equal to 50%.

Oncology Specialists, S.C.

Director of Research

Single Agent Sorafenib

Age, Categorical

United States

Region of Enrollment

Recruitment was from our clinic population. Eligible patients were those who progressed while receiving chemotherapy (docetaxel or mitoxantrone)or within 12 weeks of stopping chemo

Sigrun Hallmeyer, MD (Director of Research); Chadi Nabhan, MD (PI)

Percentage of Patients Needing a Dose Reduction.

Overall Clinical Benefit (OCB)of This Combination as Calculated by the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD).

Eligible patients were continued on the same chemotherapeutic regimen they had progressed on prior on entry into the study (Docetaxel or Mitoxantrone) with the addition of Sorafenib at 400mg twice daily. Docetaxel was given at 75 mg/m2 and Mitoxantrone was given at 12 mg/m2, both once every 21 days and both combined with Prednisone at 5mg twice daily. A maximum of 6 cycles of Sorafenib plus chemotherapy were allowed. Patients without objective disease progression after combination therapy was complete were allowed to receive Sorafenib monotherapy until disease progression.

PSA -Biochemical Response

Eligible patients were continued on the same chemotherapeutic regimen they had progressed on prior on entry into the study (docetaxel or mitoxantrone) with the addition of Sorafenib at 400mg twice daily. Docetaxel was given at 75 mg/m\^2 and mitoxantrone was given at 12 mg/m\^2, both once every 21 days and both combined with prednisone at 5mg twice daily. A maximum of 6 cycles of sorafenib plus chemotherapy were allowed. Patients without objective disease progression after combination therapy was complete were allowed to receive sorafenib monotherapy until disease progression.

Anti-Inflammatory Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Hormones

Prednisolone

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

ARD6562, Docetaxel

Atsushi NAKAMURA

* To evaluate the overall tumor response rate in subjects with metastatic hormone refractory prostate cancer
* To evaluate PSA (tumor marker) response rate
* To evaluate safety

PhII One Label Non-Comparative Trial in Metastatic Hormone Refractory Prostate Cancer in Combination With Prednisolone

A Multicenter Phase II Open Label Non-Comparative Trial of RP56976 Administered Every Three Weeks in Combination With Daily Prednisolone for Metastatic Hormone Refractory Prostate Cancer

Sanofi

Symptoms and General Pathology

Neoplasm Metastasis

Neoplastic Processes

Pharmaceutical Solutions

Abiraterone Acetate

Prednisone

Radiopharmaceuticals

Radium Ra 223 dichloride

Mineralocorticoids

Glucocorticoids

Hormone Antagonists

Antineoplastic Agents, Hormonal

Cytochrome P-450 Enzyme Inhibitors

All subjects receive concurrent administration of Radium Ra223 Dichloride and Abiraterone Acetate plus Prednisone

Radium Ra 223 dichloride - A targeted alpha particle-emitting pharmaceutical (a radiopharmaceutical drug) is a ready-to-use solution for intravenous injection containing the drug substance radium dichloride. The active moiety is the alpha particle emitting nuclide Ra-223, present as a divalent cation (223Ra2+) and Abiraterone Acetate - A CYP17 inhibitor, indicated in combination with prednisone for the treatment of subjects with metastatic castration-resistant prostate cancer. Administration of Abiraterone Acetate may result in mineralocorticoid-related adverse events (AEs), due to CYP17 inhibition. Therefore, Abiraterone Acetate is administered in combination with Prednisone to reduce the frequency of these AEs.

Concurrent use of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone

Neal D Shore, MD

This is an open label study designed to examine the effects on concurrent administration of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone in subjects with symptomatic castrate resistant prostate cancer and with bone metastases, in both the pre- and post- chemotherapy setting. Both medications are approved by the US Food and Drug Administration for this indication.

Approximately 40 subjects will be enrolled to obtain 30 evaluable subjects. All subjects will receive Radium Ra 223 dichloride every 4 weeks for a total of 6 doses over 24 weeks and concurrent Abiraterone Acetate plus Prednisone for a minimum duration of 26 weeks.

Subjects will be evaluated 30 days after the last dose of Radium Ra 223 dichloride. All adverse events deemed to be study related will be followed until resolution. Including screening, the total duration of the study is 32 weeks.

Open Label Phase Two Trial of Radium Ra 223 Dichloride With Concurrent Administration of Abiraterone Acetate Plus Prednisone in Symptomatic Castration-Resistant (Hormone-Refractory) Prostate Cancer Subjects With Bone Metastasis

Bone imaging response was assessed at baseline and at EOT visit. Progression was defined as two or more additional lesions in comparison to the baseline.

Determination of measurable disease progression or response was based on modified RECIST criteria. Reported is the number of participants with either a partial or complete response, and who had radiological extraskeletal progression.

Following Quality of Life questionnaires were given at each visit:

FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the PCS (Range 1-156, higher scores better).

The FACT-General (FACT-G) is a 28 item QOL measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), Emotional (0-24) Well-being, and Satisfaction with Treatment was not assessed for this study (The total range was between 1-108, higher scores better)

FACT-TOI is derived from the sum of the Physical Well-Being, Functional Well-Being, and Prostate Cancer subscale scores; a sensitive measure of patient-reported health (Range 1-104, higher scores better)

PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better).

Improvement in Bone Pain was assessed using the Bone Pain Inventory (BPI)

1. Pain Severity: Pain severity is the composite of scores of worst pain, least pain, average pain, and pain now. CMI criteria: Decrease \>30% at two consecutive visits in Pain Severity Score in 24 hours without an increase in analgesic use.
2. Pain interference: Pain interference is the composite scores on general activity, mood, walking ability, normal work, relationships with others, sleep and enjoyment of life. CMI criteria: Decrease by 1.25 points or more compared with baseline at two consecutive visits.
3. Transient Pain Flare: Based on the work of Atkinson et al, a transient pain flare was assessed by pain at its worst in 24 hours. CMI criteria: \> 2 points on the BPI-SF Worst Pain scale and subsequent reduction after initiation of Ra-223 and during the first 3 cycles.

All adverse events relevant to advanced mCRPC subjects as well as adverse events of interest for both Abiraterone Acetate plus Prednisone and Radium Ra 223 dichloride will be reported.

Bayer

Carolina Research Professionals, LLC

Name of active ingredient Radium Ra 223 dichloride Dose 50 kBq/kg body weight Route of Administration Intravenous Duration of Treatment One injection every 4 weeks X 6 injections maximum.

Name of active ingredient Abiraterone Acetate plus Prednisone Dose 1000 mg/day and 5 mg BID Route of Administration Oral Duration of Treatment 26 weeks minimum duration. There is no maximum duration.

Radium 223 With Concomitant Abiraterone Acetate and Prednisone

Non-Hispanic or Latino

Caucasian

African American

Race/Ethnicity, Customized

Dr. Neal D. Shore, MD, FACS, CPI

FACT-P Total Scale

FACT-G Total Scale

Treatment Outcome Index (FACT-TOI)

Prostate Cancer Subscale (PCS)

Physical Well-being

Functional Well-being

Emotional Well-being

Social Well-being

Improvement at the EOT visit was defined as increase from baseline of \>= 10 points for FACT-P Total Scale. \>9 points for FACT-G Total and FACT-TOI scales, and \>=3 points for the remaining scales.

Number and Percentage of Participants With Clinically Meaningful Improvement (Between Baseline and End of Treatment) in Quality-of-Life Determined by the Minimum Increase From Baseline in Scores as Per the QOL CMI Criteria

Overall Adverse Events

Grade I or II Adverse Events

Treatment Related Adverse Events

Safety Data Was Analyzed and Summarized in Subjects Who Receive at Least One Infusion of Radium Ra 223 Dichloride. Number of Adverse Events Are Being Reported.

ALP (Baseline)

ALP (EOT)

PSA (Baseline)

PSA (EOT)

Alkaline Phosphatase (ALP) and Prostate Specific Antigen (PSA) Levels Before and After Treatment

Baseline

Radiologic Assessment Mean Number of Bone Lesions Before and After the Treatment

Stable Disease

Progression

Bone Imaging Response (Number of Participants With Progression and Stable Disease)

Pain Severity

Pain Interference

Transient Pain Flare

Number and Percentage of Participants With Clinically Meaningful Improvement (CMI) in Pain (Between Baseline and End of Treatment)

Partial or complete response

Overall Response Rate

Adenocarcinoma

Vaccines

Immunomodulating Agents

Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with a PAP-GM-CSF. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.

Sipuleucel-T

Each dose of APC-Placebo contains approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.

APC-Placebo

Paul Schellhammer, MD

Provenge is an investigational product designed to activate a man's own antigen presenting cells, a type of immune cell, so that they can detect prostate cancer cells and initiate an immune response against them.

Having completed Phase 1 and Phase 2 clinical trials, Provenge is now at the Phase 3 level. One important Phase 3 trial of Provenge has been completed; the current trial is also a Phase 3 study.

If you decide to participate and are eligible, you will be enrolled in the study and randomly assigned to receive either active product or placebo. There are two chances in three that you will receive Provenge. After receiving treatment, you will be monitored at regular intervals until the study endpoints are met. At the end of the trial, men who received placebo will have the opportunity to be treated with active product in another study.

The trial is being conducted at multiple study centers throughout the United States. The trial is a double-blind, placebo-controlled trial. Participants must meet specific eligibility criteria. Study personnel will determine your eligibility in a telephone interview and through routine medical tests (physical exam, blood tests, imaging scans) done at a study center.

If you qualify for and decide to participate in the trial, you will have three product administrations over the course of one month.

Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy

A Randomized, Double Blind, Placebo Controlled Phase 3 Trial of Immunotherapy With Autologous Antigen Presenting Cells Loading With PA2024 (Provenge(R), APC8015) in Men With Metastatic Androgen Independent Prostatic Adenocarcinoma

Time from randomization until death due to any cause.

Measured by imaging studies; confirmed by independent imaging review

Dendreon

Liz Smith

Safety population: All subjects randomized to each arm who underwent at least one leukapheresis procedure. Not all randomized subjects underwent at least one leukapheresis procedure.

All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.

All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Taxotere and Doxil to Treat Advanced Androgen-Independent Prostate Cancer	NCT00456989	Prostate Cancer	Taxotere Doxil	18 Years -	University of Louisville
Study of Taxotere and Doxil to Treat Advanced Androgen-Independent Prostate Cancer	NCT00456989	Prostate Cancer	Taxotere Doxil	18 Years -	University of Louisville
Thalidomide and Doxil® in Patients With Androgen Independent Prostate Cancer (AIPC)	NCT00307294	Prostate Cancer	Thalidomide Doxil	18 Years -	University of Pittsburgh
Sorafenib to Overcome Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer	NCT00414388	Prostate Cancer	Sorafenib	18 Years - 90 Years	Oncology Specialists, S.C.
PhII One Label Non-Comparative Trial in Metastatic Hormone Refractory Prostate Cancer in Combination With Prednisolone	NCT00291005	Prostatic Neopl...	ARD6562, Doceta...	20 Years - 74 Years	Sanofi
PhII One Label Non-Comparative Trial in Metastatic Hormone Refractory Prostate Cancer in Combination With Prednisolone	NCT00291005	Prostatic Neopl...	ARD6562, Doceta...	20 Years - 74 Years	Sanofi
Open Label Phase Two Trial of Radium Ra 223 Dichloride With Concurrent Administration of Abiraterone Acetate Plus Prednisone in Symptomatic Castration-Resistant (Hormone-Refractory) Prostate Cancer Subjects With Bone Metastasis	NCT02097303	Prostate Cancer	Concurrent use ...	18 Years -	Carolina Research Professionals, LLC
Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy	NCT00065442	Prostate Cancer	Sipuleucel-T APC-Placebo	18 Years -	Dendreon

Spots Global Cancer Trial Database for aipc

Every month we try and update this database with for aipc 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 aipc

Every month we try and update this database with for aipc 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 aipc 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.