Phase II Trial of Flavopiridol and Cisplatin in Advanced Epithelial Ovarian and Primary Peritoneal Carcinomas
I. Determine the response rate, time to progression, and survival in patients with advanced
ovarian epithelial or primary peritoneal cancer treated with cisplatin and flavopiridol.
II. Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are accrued to two separate groups (Group 2
closed to accrual as of 3/10/06) .
GROUP 1: Patients receive cisplatin IV over 2 hours and flavopiridol IV over 24 hours on day
1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable
GROUP 2 (Closed to accrual as of 3/10/06): Patients receive cisplatin IV over 2 hours and
flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of
disease progression or unacceptable toxicity.
Patients are followed every 3 months for up to 3 years.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR)
A Complete Response (CR) is defined as the disappearance of all target lesions and normalization of tumor biomarkers. A Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4-6 weeks apart.
United States: Food and Drug Administration
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