CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Docetaxel and Gemcitabinedrug
Likely dose
Docetaxel 75 mg/m² IV over 15-30 minutes on day 1 followed by gemcitabine 800 mg/m² IV over 30 minutes on days 1 and 8 of each 21-day cycleAI-extracted
Key inclusion· 5
  • Histologically confirmed epithelial ovarian cancer or primary peritoneal carcinoma
  • Platinum-resistant disease: progression during or relapse <6 months after most recent platinum-based chemotherapy
  • Measurable or evaluable disease (elevated CA-125 ≥100 confirmed on 2 separate occasions ≥2 weeks apart, or imaging-based measurable disease)
  • Age ≥18 years
Key exclusion· 3
  • Prior treatment with gemcitabine or docetaxel
  • Peripheral neuropathy grade ≥2
  • Underlying medical, psychiatric, or social conditions precluding receipt of treatment

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

Search/NCT00183794
NCT00183794Phase 2Completed

Phase II Clinical Trial of Docetaxel in Combination With Gemcitabine in Platinum-Resistant Ovarian Cancer and Primary Peritoneal Carcinoma

University of Southern California·interventional·Posted Sep 16, 2005·Updated May 22, 2014

In Brief

A Phase 2 clinical trial evaluating Docetaxel and Gemcitabine for Ovarian Carcinoma and Peritoneal Neoplasms. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This study is for patients with advanced ovarian cancer that has reappeared after treatment with conventional therapy. The purpose of this study is to determine if the combination of docetaxel and gemcitabine will be effective in reducing or eliminating the tumor(s) in patients with ovarian cancer. Docetaxel is approved by the Food and Drug Administration (FDA) for the treatment of breast and lung cancer; gemcitabine is approved by the FDA for the treatment of pancreatic and lung cancer. Neither docetaxel nor gemcitabine are approved for the treatment of ovarian cancer. Both drugs have been shown to decrease the size of ovarian cancer tumors.

Study Details

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

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartNov 1, 2002
Primary CompletionMay 1, 2009
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 20.8 years ago

Interventions

Docetaxel and Gemcitabinedrug

Docetaxel 75 mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8 of each 3 weeks (21 days) cycle.