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NCT01081262 · ClinicalTrials.gov registry record · Phase 3
Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer
A Phase 3 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
- 20
- Study locations
NCT01081262: Active Phase 3 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, sponsored by National Cancer Institute (NCI).
NCT01081262 is a Phase 3 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 50 participants, below the 123-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (59% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01081262, a Phase 3 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 50 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase III trial studies carboplatin given together with paclitaxel with or without bevacizumab to see how well it works compared with oxaliplatin given together with capecitabine with or without bevacizumab as first-line therapy in treating patients with newly diagnosed stage II-IV, or recurrent (has come back) stage I epithelial ovarian or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. It is not yet known which regimen of combination chemotherapy given together with or without bevacizumab is more effective in treating epithelial ovarian cancer or fallopian tube cancer.
Primary Outcome
Overall survival is defined as the duration of time from study entry to time of death, or the date of last contact.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Capecitabine
- DRUG Oxaliplatin
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Bevacizumab
Study Locations (20)
California
- 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
- Bay Area Breast Surgeons Inc - Emeryville
- Epic Care Partners in Cancer Care - Emeryville
- Valley Medical Oncology Consultants-Fremont - Fremont
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Contra Costa Regional Medical Center - Martinez
- El Camino Hospital - Mountain View
- Wilma Chan Highland Hospital - Oakland
- Alta Bates Summit Medical Center - Summit Campus - Oakland
- Bay Area Tumor Institute - Oakland
- Hematology and Oncology Associates-Oakland - Oakland
- Tom K Lee Inc - Oakland
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- University of South Alabama Mitchell Cancer Institute - Mobile
Arizona
- Saint Joseph's Hospital and Medical Center - Phoenix
Arkansas
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2010-10-12 |
| Est. Completion | 2026-03-12 |
| Phase | Phase 3 |
What the registry record for NCT01081262 still lists
NCT01081262 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 123-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (59% lower).
The record links to 10 conditions, with Recurrent Ovarian Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT01081262 names 20 study sites across 4 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT01081262 about?
NCT01081262 is a clinical study titled "Carboplatin and Paclitaxel or Oxaliplatin and Capecitabine With or Without Bevacizumab as First-Line Therapy in Treating Patients With Newly Diagnosed Stage II-IV or Recurrent Stage I Epithelial Ovarian or Fallopian Tube Cancer". This randomized phase III trial studies carboplatin given together with paclitaxel with or without bevacizumab to see how well it works compared with oxaliplatin given together with capecitabine with or without bevacizumab as first-line therapy in treating patients with newly diagnosed stage II-IV, ...
What is the current status of trial NCT01081262?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2010-10-12. Estimated completion is 2026-03-12.
What conditions does trial NCT01081262 study?
This clinical trial studies the following conditions: Recurrent Ovarian Carcinoma, Recurrent Fallopian Tube Carcinoma, Ovarian Mucinous Cystadenocarcinoma, Borderline Ovarian Mucinous Tumor, Stage IA Fallopian Tube Cancer AJCC v6 and v7.
What interventions are being tested in trial NCT01081262?
The interventions under investigation include: Carboplatin (DRUG), Capecitabine (DRUG), Oxaliplatin (DRUG), Laboratory Biomarker Analysis (OTHER), Bevacizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01081262?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01081262 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01081262's enrollment target sits among peer trials
50 18th of 39 higher than 21 of 39 other Recurrent Ovarian Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Ovarian Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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