Ovarian Cancer Clinical Trial
Official title:
A Phase II Evaluation Of Pemetrexed (ALIMTA LY231514, IND #40061) In The Treatment Of Recurrent Or Persistent Platinum-Resistant Ovarian Or Primary Peritoneal Carcinoma
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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