TEACO: Taxotere, Eloxatin, Avastin in Cancer of the Ovary
Part of paid clinical trials in Bridgewater, New Jersey.
- Sponsor
- Sanofi
- Study ID
- NCT00296816
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Bevacizumab (Avastin®) — DRUG15 mg/kg bevacizumab administered intravenously (IV) over 30 to 90 minutes on Day 1 of every 3 week cycle for 12 months or until disease progression or unacceptable toxicity
- Docetaxel (Taxotere®) — DRUG75 mg/m\^2 docetaxel was administered IV over 1 hour on Day 1 of every 3 week cycle for 6 cycles or until disease progression or unacceptable toxicity
- Oxaliplatin (Eloxatin®) — DRUG85 mg/m\^2 Oxaliplatin was administered IV over 2 hours on Day 1 of every 3 week cycle for 6 cycles or until disease progression or unacceptable toxicity
Study Details
Feasibility study to assess a novel combination of cytotoxic agents, docetaxel and oxaliplatin, as first-line therapy in the treatment of ovarian cancer and the impact of angiogenesis inhibition for the progression and prognosis of ovarian cancer by concurrent addition of bevacizumab (Avastin®).
Key Dates
- First listed
- Feb 27, 2006
- Start date
- Mar 31, 2006
- Status verified
- Aug 2011
- Primary completion
- Aug 31, 2011
- Completion
- Aug 31, 2011
Study Design
- Enrollment
- 132 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Oxaliplatin/Docetaxel/BevacizumabParticipants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
Primary Outcome Measure
Twelve-month Progression-free Survival (PFS) Rate in Participants [ Time Frame: up to 12 months following treatment initiation ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | 08807 | - |
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