Study of Pemetrexed in the Treatment of Patients With Ovarian Cancer Who Have Failed Prior Platinum-Based Chemotherapy

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purposes of this study are to determine: - whether standard or higher doses of pemetrexed should be given to patients with ovarian or primary peritoneal cancer that has recurred; - the safety and side effects of standard and higher doses of pemetrexed given to patients with ovarian or primary peritoneal cancer that has recurred; - whether standard or higher doses of pemetrexed can help patients with ovarian or primary peritoneal cancer that has recurred.

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

Details

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

Criteria

Inclusion Criteria:

• Patient must have been diagnosed with ovarian or primary peritoneal cancer

• Patient must have had 1 or 2 prior platinum-based chemotherapeutic regimens.

• Patient must have adequate health status.

• Patient compliance and geographic proximity that allow for adequate follow up is required.

• Signed informed consent from the patient or legal representative is required.

Exclusion Criteria:

• Patient is pregnant or breast-feeding

• Patient has 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.

• Patient has previously participated in another study investigating pemetrexed.

• Patient is unable or unwilling to take folic acid, vitamin B12 supplementation, and corticosteroids.

• Patient cannot be taking nonsteroidal anti-inflammatory drugs around the time of administration of study drug.