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

Completed · Phase 2

Conditions studied: Ovarian Cancer, Peritoneal Cancer

In brief

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.

Key facts

Study ID

NCT00461786

Run by

Eli Lilly and Company

People needed

51

Starts

2004-09-01

Expected to finish

2008-05-01

Last updated by the study team

2009-12-04

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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