NCT00489359

Trial of Pemetrexed and Carboplatin in Patients With Recurrent Ovarian or Primary Peritoneal Cancer

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer
• Primary Peritoneal Cancer

Interventions

Type	Name	Description
DRUG	Pemetrexed - Phase 1	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)
DRUG	Carboplatin - Phase 1	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)
DRUG	Pemetrexed - Phase 2	Dose determined from Phase 1: 500 mg/m\^2, administered IV, every 21 days x 6 cycles
DRUG	Carboplatin - Phase 2	Dose determined from Phase 1: AUC 6 mg/mL\*min, administered IV, every 21 days x 6 cycles

Timeline

• Start date: 2005-07-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2007-06-21
• Last updated: 2011-06-16
• Results posted: 2011-06-16

Locations

22 sites across 5 countries: Argentina, Canada, Germany, Poland, Sweden