CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Docetaxel +1 moredrug
Likely dose
Docetaxel 40 mg/m² IV and Gemcitabine 800 mg/m² IV on days 1 and 8 of each 21-day cycleAI-extracted
Key inclusion· 6
  • Histologically confirmed ovarian epithelial or peritoneal cavity cancer
  • Relapsed or refractory disease after prior first-line platinum-containing regimen
  • Platinum-sensitive or platinum-resistant disease (resistance defined as relapsed/progressive disease within 6 months of platinum completion)
  • Measurable or evaluable disease (CA-125 >70 U/mL with doubling from baseline or other evidence of progressive disease)
Key exclusion· 7
  • Prior gemcitabine or docetaxel therapy
  • More than 1 prior chemotherapy regimen (first-line platinum plus consolidation in complete response counts as 1 regimen)
  • Peripheral neuropathy >grade 1
  • Congestive heart failure, second/third degree heart block, or myocardial infarction within 3 months

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

Search/NCT00227721
NCT00227721Phase 2Completed

Phase II Trial of Weekly Gemcitabine and Docetaxel Combination Therapy for Relapsed Ovarian or Peritoneal Cancer

Robert Morris·interventional·Posted Sep 28, 2005·Updated Dec 2, 2020

In Brief

A Phase 2 clinical trial evaluating Docetaxel and Gemcitabine hydrochloride for Ovarian Cancer and Peritoneal Cavity Cancer. Completed, enrolled 30 participants across 4 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with relapsed or refractory ovarian epithelial or peritoneal cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 28, 2005
Enrollment StartFeb 1, 2004
Primary CompletionJun 1, 2011
Study CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 20.8 years ago

Interventions

Docetaxeldrug

40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days

Gemcitabine hydrochloridedrug

800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days