Carboplatin Taxol Avastin in Ovarian Cancer (OVCA)

Sponsor
Massachusetts General Hospital
Study ID
NCT00129727
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel — DRUG
    Given intravenously
  • Carboplatin — DRUG
    Given intravenously
  • Bevacizumab — DRUG
    Given intravenously

Study Details

Study Design: This ia a Phase II study. Subjects: Patients with chemotherapy naive epithelial ovarian cancer; or fallopian, primary peritoneal and papillary serous mullerian tumors will be recruited. Carboplatin and Taxol (paclitaxel) will be administered concurrently with bevacizumab after surgery for 6-8 cycles every 21 (q21) days. Bevacizumab will be omitted in the first cycle, immediately post-operatively. This will be followed by one year of bevacizumab q21. Outcomes: Outcomes include toxicity, response rate, and progression free survival.

Key Dates

First listed
Aug 12, 2005
Start date
Jun 30, 2005
Status verified
Apr 2016
Primary completion
Feb 28, 2009
Completion
Feb 28, 2009

Study Design

Enrollment
62 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase II
    Paclitaxel carboplatin bevacizumab

Primary Outcome Measure

PFS [ Time Frame: Median PFS in months - up to 5 years ]

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