CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 86 enrolled
Drug / intervention
Pemetrexed - Phase 1 +3 moredrug
Likely dose
Pemetrexed - Phase 1 900 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00489359
NCT00489359Phase 2Completed

A Phase 1 and 2 Clinical Trial of ALIMTA® (Pemetrexed) in Combination With Carboplatin in Patients With Recurrent Ovarian or Primary Peritoneal Cancer

Eli Lilly and Company·interventional·Posted Jun 21, 2007·Updated Jun 16, 2011

In Brief

A Phase 2 clinical trial evaluating Pemetrexed - Phase 1, Carboplatin - Phase 1, and 2 other interventions for Ovarian Cancer and Primary Peritoneal Cancer. Completed, enrolled 86 participants across 22 sites in 5 countries.

Detailed Summary

The purpose of this study is to determine efficacy of the combination therapy of pemetrexed and carboplatin as treatment for patients with platinum-sensitive ovarian cancer. This study also includes patients with primary peritoneal cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Canada, Germany, Poland, Sweden
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 21, 2007
Enrollment StartJul 1, 2005
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 19.0 years ago

Interventions

Pemetrexed - Phase 1drug

500, 600, 700, 800, or 900 milligrams per square meter (mg/m\^2), administered intravenously (IV), every 21 days x 6 cycles, dose escalate to Maximum Tolerated Dose (MTD)

Carboplatin - Phase 1drug

area under the concentration time curve (AUC) 5 or 6 mg/mL\*min, administered intravenously (IV), every 21 days x 6 cycles, dose escalation to Maximum Tolerated Dose (MTD)

Pemetrexed - Phase 2drug

Dose determined from Phase 1: 500 mg/m\^2, administered IV, every 21 days x 6 cycles

Carboplatin - Phase 2drug

Dose determined from Phase 1: AUC 6 mg/mL\*min, administered IV, every 21 days x 6 cycles