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NCT00127920 · ClinicalTrials.gov registry record · Phase 2
Pilot Study of Taxol, Carboplatin, and Bevacizumab in Advanced Stage Ovarian Carcinoma Patients
A Phase 2 study of Ovarian Neoplasms, sponsored by Gynecologic Oncology Associates.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT00127920 is a Phase 2 study of Ovarian Neoplasms that has completed, run by Gynecologic Oncology Associates. The registered enrollment target is 20 participants, below the 367-participant average among 38 other Ovarian Neoplasms trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT00127920, a Phase 2 study of Ovarian Neoplasms, has completed, sponsored by Gynecologic Oncology Associates.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study Summary
The most likely way to improve survival and cure rates in treating ovarian cancer, fallopian tube epithelial cancer, and peritoneal cancer is with maximal "upfront" therapy (Morrow \& Curtin, 1998). This involves an optimal primary tumor debulking surgery. The most active chemotherapy agents should then be promptly administered. Taxol and Carboplatin or Cisplatin have become the standard" first line" therapy because of proven survival benefits with those regimens in treating advanced ovarian adenocarcinoma patients. New chemotherapy agents like bevacizumab have demonstrated increased overall and progression free survival benefits in metastatic colorectal cancer patients and are being studied for their potential contributory impact on the current standard of treatment. Since no triplet regimen has demonstrated compelling superiority, the combination of taxol, carboplatin, and bevacizumab is intriguing because of their potential synergy, distinct mechanisms of action, and non-overlapping toxicity. The null hypothesis (Ho) is that the drug regimen will demonstrate an 80% patient response rate (RR). The alternative Hypothesis (H1): The triplet drug regimen will demonstrate a significantly higher patient response rate than standard therapy. Hypothesis (H2): The triplet drug regimen will demonstrate a significantly more favorable patient time to tumor progression rate than standard therapy.
Conditions Studied
Interventions
- DRUG Avastin
Study Locations (2)
California
- Gynecologic Oncology Associates - Newport Beach
Florida
- Florida Hospital College of Health Sciences - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2004-08 |
| Est. Completion | 2012-10 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00127920
The ClinicalTrials.gov registry entry for NCT00127920 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 367-participant average among 38 other Ovarian Neoplasms trials with a reported enrollment target (95% lower). The listed sponsor is Gynecologic Oncology Associates, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Ovarian Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which Avastin is the first listed.
NCT00127920 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Florida.
Frequently Asked Questions
What is clinical trial NCT00127920 about?
NCT00127920 is a clinical study titled "Pilot Study of Taxol, Carboplatin, and Bevacizumab in Advanced Stage Ovarian Carcinoma Patients". The most likely way to improve survival and cure rates in treating ovarian cancer, fallopian tube epithelial cancer, and peritoneal cancer is with maximal "upfront" therapy (Morrow \& Curtin, 1998). This involves an optimal primary tumor debulking surgery. The most active chemotherapy agents should ...
What is the current status of trial NCT00127920?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2004-08. Estimated completion is 2012-10.
What conditions does trial NCT00127920 study?
This clinical trial studies the following conditions: Ovarian Neoplasms.
What interventions are being tested in trial NCT00127920?
The interventions under investigation include: Avastin (DRUG).
Who is sponsoring clinical trial NCT00127920?
This trial is sponsored by Gynecologic Oncology Associates, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00127920 being conducted?
This trial has 2 study locations across California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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