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

Lilly

Status and phase

Completed

Phase 2

Conditions

Ovarian Neoplasms

Primary Peritoneal Cancer

Treatments

Drug: Pemetrexed

Study type

Interventional

Funder types

Industry

Identifiers

NCT00109096

9710

H3E-MC-JMHF

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.