A Phase 2 interventional study of pemetrexed disodium in Ovarian Cancer and Primary Peritoneal Cavity Cancer, sponsored by Gynecologic Oncology Group. Completed at 35 sites in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2014-02-14.
Sponsored by Gynecologic Oncology Group · Phase 2, Interventional, and Treatment
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:
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.
2,757 studies on the registry are indexed under Ovarian Neoplasms; 735 are open to participants now.
This study's planned enrollment of 51 is below the median of 59 across 2,075 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Gynecologic Oncology Group is the lead sponsor of 188 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed 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
Platinum-resistant or refractory disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
One prior noncytotoxic (biologic or cytostatic) regimen allowed for management of recurrent or refractory disease, including, but not limited to, the following:
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No non-steroidal anti-inflammatory drugs (NSAIDs) for 2-5 days before, during, and for 1-2 days after study drug administration
Antitumor activity
Toxicity
The record gives a start of Jul 2004 and a primary completion of Dec 2006. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pemetrexed