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

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.

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.