CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
gemcitabine +1 moredrug
Likely dose
Gemcitabine 1250 mg/m² IV on days 1 and 8, and cisplatin 75 mg/m² IV on day 1, every 21 days for up to 6 cyclesAI-extracted
Key inclusion· 3
  • ✓ECOG performance status 0–2
  • ✓Surgically treated (operated) patients
  • ✓Stage III–IV epithelial ovarian cancer
Key exclusion· 1
  • ✕Any prior chemotherapy or radiation therapy

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

Search/NCT00191334
NCT00191334Phase 2Completed
CompareCT.gov

Phase II Study of Gemcitabine Plus Cisplatin as First-Line Therapy in Patients With Epithelial Ovarian Cancer

Eli Lilly and Company·interventional·Posted Sep 19, 2005·Updated Mar 27, 2009

In Brief

A Phase 2 clinical trial evaluating gemcitabine and cisplatin for Ovarian Cancer. Completed, enrolled 50 participants across 5 sites.

Detailed Summary

The primary endpoint of this study is to assess the objective tumor response rate in patients with advanced epithelial ovarian cancer receiving combination of Gemcitabine at a dose 1250 mg/m2 (Day 1 and 8) with Cisplatin 75 mg/m2 (Day 1) as first-line treatment

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer
CountriesRussia
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartDec 1, 2004
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.8 years ago

Interventions

gemcitabinedrug

1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity

cisplatindrug

75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity