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Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Recurrent Ovarian Epithelial Cancer Clinical Trial

Official title:
Phase II Trial of Flavopiridol and Cisplatin in Advanced Epithelial Ovarian and Primary Peritoneal Carcinomas

Clinical Trial Summary

This phase II trial is studying how well giving cisplatin together with flavopiridol works in treating patients with advanced ovarian epithelial cancer or primary peritoneal cancer. Drugs used in chemotherapy, such as cisplatin and flavopiridol, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

Clinical Trial Description

OBJECTIVES:

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 30 minutes and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

GROUP 2 (Closed to accrual as of 3/10/06): Patients receive cisplatin IV over 30 minutes 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Recurrent Ovarian Epithelial Cancer
  • Recurrent Primary Peritoneal Cavity Cancer
  • Stage IIIA Ovarian Epithelial Cancer
  • Stage IIIA Primary Peritoneal Cavity Cancer
  • Stage IIIB Ovarian Epithelial Cancer
  • Stage IIIB Primary Peritoneal Cavity Cancer
  • Stage IIIC Ovarian Epithelial Cancer
  • Stage IIIC Primary Peritoneal Cavity Cancer
  • Stage IV Ovarian Epithelial Cancer
  • Stage IV Primary Peritoneal Cavity Cancer
Clinical Trial Details
NCT number NCT00083122
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date April 2004
Completion date May 2012
View Details
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