Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Fallopian Tube Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Antimetabolites

Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.

Patients will receive pazopanib 800mg PO daily on days 1-21 of treatment cycles

pazopanib

Linda Duska, MD

Ovarian cancer is the leading cause of gynecologic cancer deaths, and the fifth most common cause of cancer deaths in women. While approximately 75% of patients with epithelial ovarian cancer will respond to first-line chemotherapy with platinum and paclitaxel, most patients with advanced stage epithelial ovarian cancer will experience disease recurrence. Pazopanib is a novel agent has recently been approved for the treatment of subjects with advanced renal cell carcinoma (RCC), and preclinical studies suggest it may be effective in other cancers such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and safety of a novel agent, pazopanib, as an adjunct to a standard treatment, gemcitabine, for recurrent or persistent ovarian cancer. This is an open label study in which subjects will be randomized 1:1 to receive 4 cycles of either gemcitabine, or gemcitabine with pazopanib. Gemcitabine will be administered as an IV infusion weekly on days 1 and 8 of a 21 day cycle. Subjects randomized to receive pazopanib will take 800 mg daily during the 21 day cycle. All subjects will be monitored for toxicity and other indicators of safety (labs, physical exams, vitals) at intervals throughout the treatment cycles. Subjects will be followed for up to 5 years following the conclusion of treatment to evaluate efficacy. The primary endpoints of the study are progression free survival and overall survival, which will be assessed at three years.

A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer

A Randomized Open Label Phase II Study of Weekly Gemcitabine Plus Pazopanib Versus Weekly Gemcitabine Alone in the Treatment of Patients With Persistent or Relapsed Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma

Progression-Free Survival (PFS) is defined as the duration of time from study entry to time of recurrence/progression or death from any cause, whichever occurs first.

Adverse events will be evaluated using CTCAE criteria from the start of study treatment until 30 days following the last dose of study treatment

Novartis

Linda R Duska

Associate Professor, Division of Gynecology Oncology, University of Virginia

Gemcitabine: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.

Gemcitabine: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.

pazopanib: Patients will receive pazopanib 800mg PO daily on days 1-21 of treatment cycles

Gemcitabine + Pazopanib

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

All eligible and randomized participants who received study treatment.

Our study is limited by lack of placebo control, independent pathology and radiologic review, and correlative science. We did not collect data regarding quality of life, and the study was performed in an unselected patient population.

Progression-free Survival

Number of Participants With Adverse Events

Overall Study

Pembrolizumab

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Combination Therapy: Pembrolizumab (experimental use) and Paclitaxel (standard use). All trial treatments will be administered on an outpatient basis. One cycle equals 21 days. The first cycle is 28 days with Pembrolizumab given on day 8 in order to determine paclitaxel tolerance.

Pembrolizumab: 200 mg, every (Q) 3 weeks, via intravenous (IV) infusion, until progression or toxicity (or up to 24 months). The first cycle will begin on day 8.

Paclitaxel: 80 mg/m\^2, Q week for 3 weeks, via IV infusion, until progression or toxicity (or complete response if at least 6 cycles, at the discretion of the investigator and participant). Cycle 1 will have an extra lead in week (4 weeks total) with Paclitaxel only on week 1.

Robert Wenham, M.D.

The purpose of this study is to find out if the combination of Paclitaxel once per week with Pembrolizumab once every 3 weeks will help participants with this disease. Researchers want to find out the effectiveness of the drug combination to improve the delay of cancer progression or death and compare it to historical data for weekly paclitaxel alone, and assess safety.

Dose Dense Paclitaxel With Pembrolizumab (MK-3475) in Platinum Resistant Ovarian Cancer

Phase 2 Trial of Dose Dense (Weekly) Paclitaxel With Pembrolizumab (MK-3475) in Platinum Resistant Recurrent Ovarian Cancer

6-month progression-free survival of the combination of weekly paclitaxel with pembrolizumab (MK-3475) for those patients who received treatment and were evaluable (had one response assessment scan by RECIST 1.1) . 6-month PFS: The proportion of patients at 6 months alive without progressive disease. Progressive Disease (PD): Sum of the longest diameters (SLD) increased by at least 20% from the smallest value on study (including baseline, if that is the smallest).

Safety of the combination of paclitaxel weekly with pembrolizumab every 3 weeks (Q3W). Serious Adverse Events and Adverse Events will be reported in that Results Data section, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V4.0.

Proportion of participants who respond to the regimen by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. RECIST v1.1: Complete Response (CR) - Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to \<10 mm in short axis. Partial Response (PR) - At least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters. RR=CR + PR.

DCR: The percentage of participants complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents. Stable Disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. DCR=CR + PR + (SD x 2 mo.)

Duration of Response in months. DOR= Duration from first observation of partial response to the time of disease progression.

OS: The time from randomization until death from any cause.

Merck Sharp & Dohme LLC

H. Lee Moffitt Cancer Center and Research Institute

Combination Therapy: Pembrolizumab (experimental use) and Paclitaxel (standard use). All trial treatments will be administered on an outpatient basis. One cycle equals 21 days. The first cycle is 28 days with Pembrolizumab given on day 8 in order to determine paclitaxel tolerance.

Pembrolizumab: Pembrolizumab: 200 mg, every (Q) 3 weeks, via intravenous (IV) infusion, until progression or toxicity (or up to 24 months). The first cycle will begin on day 8.

Paclitaxel: Paclitaxel: 80 mg/m\^2, Q week for 3 weeks, via IV infusion, until progression or toxicity (or complete response if at least 6 cycles, at the discretion of the investigator and participant). Cycle 1 will have an extra lead in week (4 weeks total) with Paclitaxel only on week 1.

Combination Therapy

Age, Categorical

Ethnicity (NIH/OMB)

Number of participants who received at least one dose of study drugs.

Primary outcome only incorporated patients who received treatment \& completed first RECIST 1.1 response assessment. Does not reflect an intent-to-treat population.

All patients enrolled \& received one dose of drug were included for safety analysis.

Although patients had a recurrence of cancer within 6 months of a platinum drug ("platinum-resistant"), 43% of patients were enrolled on study \>6 months from last platinum-based therapy (including maintenance) \& 16.2% were greater than 12 months.

Robert M. Wenham, MD, MS, FACOG, FACS

Progression-free Survival (PFS) at 6 Months

SAEs related to study treatment

AEs related to study treatment

All participants who received at least one dose of study drugs.

Occurrence of Adverse Events

Response Rate (RR)

Disease Control Rate (DCR)

Duration of Response (DOR)

Median Overall Survival (OS)

Immune System Diseases

Uterine Cervical Neoplasms

Hypersensitivity

Vaginal Neoplasms

Vulvar Neoplasms

Uterine Neoplasms

Endometrial Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Vulvar Diseases

Vaginal Diseases

Vaginal Cancer

Vulvar Cancer

Dermatologic Agents

Coal Tar

This study will collect patient demographic, oncology history, and physician reported outcome information following the initial round of chemotherapy received after a commercial ChemoFx® Final Report for the generation of hypotheses of potential patient cohorts for further sub-studies.

The traditional treatment course for new cases of many cancers is cytoreductive surgery followed by chemotherapy. Unfortunately, despite high initial response rates to treatment, the majority of patients recur. The use of ineffective chemotherapy can result in unnecessary toxicity and costs, delay of more effective treatment, and the potential for the development of cross-resistance to additional drugs. The ability to individualize therapy by providing the treating physician with ex vivo response information on a panel of drugs should aid in the selection of effective therapy for individual patients, thus resulting in improved outcomes.

ChemoFx® is a drug response marker that quantifies an individual cancer patient's probable tumor response to various chemotherapeutic and biologic agents-providing both sensitivity and resistance information. In a retrospective study, it was demonstrated that patients treated with a regimen that the ChemoFx® test said the patients' cells would be sensitive to, corresponded to a 3 times longer progression free interval.

In the PT-206 ChemoFx PRO® study, patients will be followed through treatment, until the patient progresses or a significant change in chemotherapy occurs. This data will be collected and analyzed to identify potential patient cohorts for the development of hypotheses for future sub-study analysis. Also, tumor pathology slides and excess tumor cells (if available) will be used to characterize common polymorphisms in drug metabolizing enzymes as well as other molecular markers potentially associated with tumor response.

The PT-206 ChemoFx PRO® Study seeks to enroll an estimated 3,000 patients from 150 academic and community-based physicians in the U.S. The patients will be treated with drugs and/or drug combinations based on the medical judgment of the treating physician. This study is not randomized.

Leftover tumor cells from the test and pathology slides will be collected and stored to look for potential genetic variations related to drug pathway genes to identify patterns associated with clinical outcome.

ChemoFx® PRO - A Post-Market Data Collection Study

ChemoFx® PRO - A Post-Market Data Collection Study Utilizing Physician Reported Outcomes

Precision Therapeutics

Respiratory Tract (Lung and Bronchial) Diseases

Adenocarcinoma

Sarcoma

Mesothelioma

Mesothelioma, Malignant

Carcinoid Tumor

Soft Tissue Sarcoma

Malignant Mesothelioma

Karl Williams, M.D.

The purpose of this research study is to collect information from patient's medical records that had a test called ChemoFx® ordered and to understand how doctors may have used the results of the ChemoFx® to treat patients with cancer.

While studies support the clinical use of ChemoFx® in cancer patients, additional data are needed to further assess the utilization of this product in clinical practice. Such post-market data and information could be employed for product improvement as well as for the development of standards and regulations. This is a multicenter registry study of 3,000 patients with solid tumors. The study is not randomized, nor is it interventional in that the treating physician is free to choose how to employ ChemoFx® results in the clinical management of individual patients. Sites will be selected by Precision's clinical trials team based on past commercial usage of ChemoFx®.

Subjects who may be enrolled in this study are those who have been diagnosed with a solid tumor malignancy and for whom ChemoFx® has been ordered. ChemoFx® is ordered through the normal commercial process and is therefore billed to the patient's medical insurance.

All subjects will be appropriately consented before any study-specific data are collected. A limited dataset of patient demographics, oncology history, and therapeutic intervention will be collected in addition to ChemoFx® assay usage. Subjects will be treated based on the medical judgment of their treating physician(s). Patient survival data will be collected up to five years following the ChemoFx® commercial order. Additional disease progression data may be collected by Precision's CRAs at participating sites.

Optional Cell Research

Informed consent will be obtained to document subject's consent to use excess cells remaining in Precisions' commercial laboratory for additional research. This portion of the study may involve DNA, RNA, and proteomic research. To ensure the anonymity of each subject, any identifiers that would link the sample to the subject will be removed. The samples would then have gene expression profiling and or quantitative protein expression analysis performed. The goal of the research would be to identify a set of informative genes, intermediaries, and proteins and develop predictive algorithm(s) that seek to link the expression level of the gene, gene signature, intermediary, or protein to the clinical outcome of the patient. This portion of the study does not require any additional subject procedures. Neither physicians nor their patients will receive the results of the research performed. Results will not be placed in the subjects health care records and will not affect their medical care.

DNA, RNA, and proteomic research will be conducted on excess tissue cells.

A Study of ChemoFx® Chemoresponse Assay in Solid Tumors - ChemoFx® Registry Study

A Multicenter, Post-Market Follow-up Study of ChemoFx® Chemoresponse Assay in Solid Tumors - ChemoFx® Registry Study

Digestive System Diseases

Disease Progression

Peritoneal Neoplasms

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Thomas J Rutherford, MD

Hong Ma, MD

Chemoresponse assays (lab test) measure the effect that chemotherapy treatment has on a patient's cancer cells in the lab. This test has shown success in a retrospective study in predicting how an individual patient's tumor will respond to a given chemotherapy and how treatment utilizing an agent that the test said that a patient's cells would be sensitive too corresponds to a longer progression free interval. This study will determine the ability of two tests used to predict the success of chemotherapy in recurrent, persistent, or refractory cancer of the ovaries, fallopian tube(s) or peritoneum by measuring how long patients live without progression.

The traditional treatment course for new cases of ovarian, fallopian tube, or peritoneal cancer is cytoreductive surgery followed by chemotherapy with paclitaxel in combination with carboplatin. Unfortunately, despite high initial response rates, the majority of patients recur and subsequent therapy is much less likely to be effective. The use of ineffective chemotherapy can result in unnecessary toxicity and costs, delay of more effective treatment, and the potential for the development of cross-resistance to additional drugs. The ability to individualize therapy by providing the treating physician with ex vivo response information on a panel of drugs should aid in the selection of effective therapy for individual patients, thus resulting in improved outcomes.

Resistance to chemotherapy cannot be predicted by either clinical or histological examination. Historically, the ex vivo sensitivity and resistance of tumor cells has been evaluated as a tool for predicting the clinical response of the patient to therapy. In this study, chemotherapy drugs will be tested using both the Precision Therapeutics' ChemoFx Assay and the Yale Apoptosis Assay. The assay results will be compared to clinical outcomes that will be reported at regular intervals. Blood, tumor pathology slides, and excess tumor cells (if available) will be used to characterize common polymorphisms in drug metabolizing enzymes as well as other molecular markers potentially associated with tumor response.

This is a one-arm validation trial with a goal of approximately 256 evaluable patients recruited from multiple sites. Patients will be drawn from the Yale -New Haven Medical Center and multiple additional sites as needed to meet accrual goals. The patients will be treated with FDA approved drugs and/or drug combinations based on the medical judgment of the treating physician. The study is not randomized and the results of the assay will not be used in the decision process for which agent to select for treatment, but are made available to the treating physician upon further progression.

Leftover tumor cells from the test, pathology slides, and blood samples will be collected and stored to look for potential genetic variations related to drug pathway genes to identify patterns associated with clinical outcome.

Correlation of the Chemoresponse Assay With PFS in Patients With Recurrent Epithelial Ovarian, Peritoneal, or Fallopian Tube Cancer

A Non-Interventional Prospective Study of the Correlation of the Precision Therapeutics, Inc. Chemoresponse Assay With Progression-Free Survival in Patients With Recurrent Epithelial Ovarian, Peritoneal, or Fallopian Tube Cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer	NCT01610206	Ovarian Cancer Fallopian Tube ... Peritoneal Canc...	Gemcitabine pazopanib	18 Years -	University of Virginia
Dose Dense Paclitaxel With Pembrolizumab (MK-3475) in Platinum Resistant Ovarian Cancer	NCT02440425	Ovarian Cancer	Pembrolizumab Paclitaxel	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
ChemoFx® PRO - A Post-Market Data Collection Study	NCT00669422	Ovarian Cancer Fallopian Tube ... Peritoneal Canc... Uterine Neoplas... Endometrial Can... Vaginal Cancer Vulvar Cancer Cervical Cancer		18 Years -	Precision Therapeutics
Dose Dense Paclitaxel With Pembrolizumab (MK-3475) in Platinum Resistant Ovarian Cancer	NCT02440425	Ovarian Cancer	Pembrolizumab Paclitaxel	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer	NCT01610206	Ovarian Cancer Fallopian Tube ... Peritoneal Canc...	Gemcitabine pazopanib	18 Years -	University of Virginia
A Study of ChemoFx® Chemoresponse Assay in Solid Tumors - ChemoFx® Registry Study	NCT01271959	Solid Organ Tum...		18 Years -	Precision Therapeutics
ChemoFx® PRO - A Post-Market Data Collection Study	NCT00669422	Ovarian Cancer Fallopian Tube ... Peritoneal Canc... Uterine Neoplas... Endometrial Can... Vaginal Cancer Vulvar Cancer Cervical Cancer		18 Years -	Precision Therapeutics
Correlation of the Chemoresponse Assay With PFS in Patients With Recurrent Epithelial Ovarian, Peritoneal, or Fallopian Tube Cancer	NCT00288275	Ovarian Cancer Fallopian Tube ... Peritoneal Neop...		18 Years -	Precision Therapeutics
ChemoFx® PRO - A Post-Market Data Collection Study	NCT00669422	Ovarian Cancer Fallopian Tube ... Peritoneal Canc... Uterine Neoplas... Endometrial Can... Vaginal Cancer Vulvar Cancer Cervical Cancer		18 Years -	Precision Therapeutics
Correlation of the Chemoresponse Assay With PFS in Patients With Recurrent Epithelial Ovarian, Peritoneal, or Fallopian Tube Cancer	NCT00288275	Ovarian Cancer Fallopian Tube ... Peritoneal Neop...		18 Years -	Precision Therapeutics

Spots Global Cancer Trial Database for persistent

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

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