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

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Carboplatin; Pemetrexed

Criteria

Inclusion Criteria:

• Diagnosis of ovarian or primary peritoneal cancer confirmed by pathology

• Patients must have recurrent ovarian cancer which is sensitive to platinum therapy

• Prior radiation therapy is allowed

Measurable disease as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines, or non-measurable but cancer antigen 125 (CA-125) greater than or equal to 2X upper limit.

Exclusion Criteria:

• More than 2 lines of therapy for ovarian or primary peritoneal cancer.

• Pregnant or breast feeding.

• Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.