A Study of Single Agent Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Ovarian or Primary Peritoneal Cancer

Lilly

Status and phase

Completed

Phase 2

Conditions

Peritoneal Cancer

Ovarian Cancer

Treatments

Drug: pemetrexed

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT00461786

H3E-US-JMGP

8364

Details and patient eligibility

About

The primary purpose of this trial is to estimate the drug effect on tumors in patients with ovarian or primary peritoneal cancers. Patients will receive Pemetrexed every 21 days until disease progression or unacceptable toxicity. This medication will be given over 10 minutes and may be administered intravenously (IV), through a vein in your arm. Vitamin supplementation is a required part of this study.

Enrollment

51 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically confirmed recurrent or persistent disease ovarian epithelial or primary peritoneal cancer
Measurable disease
Must have received 1 prior platinum-based (carboplatin, cisplatin, or another organoplatinum compound) chemotherapy regimen for primary disease. Patients who had not received prior paclitaxel may have received a second regimen that included paclitaxel
Treatment-free interval < 6 months after prior platinum-based therapy OR progressed during platinum-based therapy
Not eligible for a higher priority Gynecologic Oncology Group (GOG) protocol (i.e., any active phase III GOG protocol for the same patient population)

Exclusion criteria

Patients who have had prior therapy with pemetrexed
Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
Patients who have received radiation to more than 25% of marrow