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Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.


Clinical Trial Description

OBJECTIVES:

- Determine the antitumor activity of pemetrexed disodium in patients with recurrent or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer that failed higher priority treatment protocols.

- Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Beginning 7 days before and continuing until 3 weeks after the last dose of pemetrexed disodium, patients also receive oral folic acid daily and cyanocobalamin (vitamin B_12) intramuscularly every 9 weeks.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 11-22 months. ;


Study Design

Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00087087
Study type Interventional
Source Gynecologic Oncology Group
Contact
Status Completed
Phase Phase 2
Start date July 2004

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