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®) — DRUG
    15 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®) — DRUG
    75 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®) — DRUG
    85 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/Bevacizumab
    Participants 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)

FacilityCityStateZIPSite coordinators
Sanofi-Aventis Administrative OfficeBridgewaterNew Jersey08807-

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