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NCT01167712 · ClinicalTrials.gov registry record · Phase 3
Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
A Phase 3 study of Ovarian Endometrioid Adenocarcinoma and Fallopian Tube Endometrioid Adenocarcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 692
- Enrollment target
- 20
- Study locations
NCT01167712: Active Phase 3 study of Ovarian Endometrioid Adenocarcinoma and Fallopian Tube Endometrioid Adenocarcinoma, sponsored by National Cancer Institute (NCI).
NCT01167712 is a Phase 3 study of Ovarian Endometrioid Adenocarcinoma and Fallopian Tube Endometrioid Adenocarcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 692 participants, above the 256-participant average among 15 other Ovarian Endometrioid Adenocarcinoma trials with a reported enrollment target (170% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01167712, a Phase 3 study of Ovarian Endometrioid Adenocarcinoma and Fallopian Tube Endometrioid Adenocarcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 692 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III clinical trial studies two different dose schedules of paclitaxel to see how well they work in combination with carboplatin with or without bevacizumab in treating patients with stage II, III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab is a type of drug called a monoclonal antibody and blocks tumor growth by stopping the growth of blood vessels that tumors need to grow. It is not yet known whether giving paclitaxel with combination chemotherapy once every three weeks is more effective than giving paclitaxel once a week in treating patients with ovarian, primary peritoneal, or fallopian tube cancer.
Primary Outcome
First progression or death for weekly paclitaxel treatment relative to standard 3 week paclitaxel. 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.
Conditions Studied
Interventions
- DRUG Carboplatin
- PROCEDURE Computed Tomography
- DRUG Paclitaxel
- PROCEDURE Therapeutic Conventional Surgery
- BIOLOGICAL Bevacizumab
Study Locations (20)
California
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- East Bay Radiation Oncology Center - Castro Valley
- Valley Medical Oncology Consultants-Castro Valley - Castro Valley
- John Muir Medical Center-Concord - Concord
- Bay Area Breast Surgeons Inc - Emeryville
- Kaiser Permanente-Fremont - Fremont
- Valley Medical Oncology Consultants-Fremont - Fremont
- Kaiser Permanente-Fresno - Fresno
- Marin Cancer Care Inc - Greenbrae
Arizona
- Saint Joseph's Hospital and Medical Center - Phoenix
- Mayo Clinic in Arizona - Scottsdale
- University of Arizona Cancer Center-Orange Grove Campus - Tucson
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- University of South Alabama Mitchell Cancer Institute - Mobile
Arkansas
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- University of Arkansas for Medical Sciences - Little Rock
Alaska
- Providence Alaska Medical Center - Anchorage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 692 participants |
| Start Date | 2010-09-27 |
| Est. Completion | 2026-07-02 |
| Phase | Phase 3 |
What the registry record for NCT01167712 still lists
NCT01167712 is an interventional study that assigns participants to a tested intervention. The registered 692 participants enrollment target is mid-sized for trials with a published cap, above the 256-participant average among 15 other Ovarian Endometrioid Adenocarcinoma trials with a reported enrollment target (170% higher).
The record links to 10 conditions, with Ovarian Endometrioid Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT01167712 names 20 study sites across 5 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT01167712 about?
NCT01167712 is a clinical study titled "Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer". This phase III clinical trial studies two different dose schedules of paclitaxel to see how well they work in combination with carboplatin with or without bevacizumab in treating patients with stage II, III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer. Drugs u...
What is the current status of trial NCT01167712?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 692 participants. The study started on 2010-09-27. Estimated completion is 2026-07-02.
What conditions does trial NCT01167712 study?
This clinical trial studies the following conditions: Ovarian Endometrioid Adenocarcinoma, Fallopian Tube Endometrioid Adenocarcinoma, Ovarian Serous Adenocarcinoma, Fallopian Tube Transitional Cell Carcinoma, Fallopian Tube Mucinous Adenocarcinoma.
What interventions are being tested in trial NCT01167712?
The interventions under investigation include: Carboplatin (DRUG), Computed Tomography (PROCEDURE), Paclitaxel (DRUG), Therapeutic Conventional Surgery (PROCEDURE), Bevacizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01167712?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01167712 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01167712's enrollment target sits among peer trials
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