CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
cisplatin +2 moredrug
Likely dose
Flavopiridol (alvocidib) IV plus cisplatin IV; specific dose not stated in criteria or interventionsAI-extracted
Key inclusion· 6
  • ✓Histologically confirmed ovarian epithelial or primary peritoneal cancer with advanced disease
  • ✓Measurable disease OR evaluable disease plus CA 125 ≥2 times post-treatment nadir
  • ✓Exactly 1 prior platin-containing chemotherapy regimen (e.g., paclitaxel or carboplatin-based)
  • ✓Group 1: Relapse during or <6 months after completion of post-debulking chemotherapy (platin-resistant) OR platinum-sensitive patients in second relapse after initial regimen rechallenge at first relapse
Key exclusion· 8
  • ✕No other malignancy within the past 5 years except non-melanoma skin cancer or carcinoma in situ of cervix
  • ✕No diabetes
  • ✕No peripheral neuropathy ≥grade 2
  • ✕No baseline diarrhea (≥4 stools/day)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00083122
NCT00083122Phase 2Completed
CompareCT.gov

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

National Cancer Institute (NCI)·interventional·Posted May 17, 2004·Updated May 21, 2014

In Brief

A Phase 2 clinical trial evaluating cisplatin, alvocidib, and 1 other intervention for Recurrent Ovarian Epithelial Cancer and 9 related conditions. Completed, enrolled 45 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent 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
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 17, 2004
Enrollment StartApr 1, 2004
Primary CompletionJul 1, 2010
Study CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 22.1 years ago

Interventions

cisplatindrug

Given IV

alvocidibdrug

Given IV

cisplatin/flavopiridoldrug

Given IV