A Phase 2 interventional study of cisplatin and gemcitabine hydrochloride in Ovarian Cancer and Primary Peritoneal Cavity Cancer, sponsored by Gynecologic Oncology Group. Completed at 31 sites in 2 countries. Open to female participants. Per ClinicalTrials.gov, last updated 2013-05-27.
Sponsored by Gynecologic Oncology Group · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of gemcitabine plus cisplatin in treating patients who have primary ovarian epithelial cancer or primary peritoneal cancer that is recurrent or has not responded to platinum-based chemotherapy.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive cisplatin IV over 1 hour followed by gemcitabine IV over 1 hour on days 1 and 8. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 5-14 months.
2,757 studies on the registry are indexed under Ovarian Neoplasms; 735 are open to participants now.
Browse Ovarian Neoplasms studies →Gynecologic Oncology Group is the lead sponsor of 188 studies on the registry; 1 is open to participants now.
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DISEASE CHARACTERISTICS:
Histologically confirmed primary ovarian epithelial cancer or primary peritoneal carcinoma
Bidimensionally measurable disease by physical examination or medical imaging techniques
Must have received one, and only one, prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
The record gives a start of Jan 2001 and a primary completion of Jan 2007. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2003. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Cisplatin · Gemcitabine