Ovarian Cancer Clinical Trial
Gemcitabine Plus Cisplatin in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Is Recurrent or Has Not Responded to Platinum-based Chemotherapy
Summary
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.
Full Description
OBJECTIVES:
Determine the anti-tumor activity of gemcitabine and cisplatin in patients with recurrent or refractory platinum-resistant ovarian epithelial cancer or primary peritoneal carcinoma who have failed on higher priority treatment protocols.
Determine the nature and degree of toxicity of this regimen in this patient population.
Correlate ex vivo drug sensitivity and resistance with clinical response to this regimen in these patients.
Correlate molecular markers of drug responsiveness and cellular apoptosis with ex vivo measures of drug resistance in these patients.
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed primary ovarian epithelial cancer or primary peritoneal carcinoma
Recurrent or persistent disease
Bidimensionally measurable disease by physical examination or medical imaging techniques
Sonography is acceptable if lesions are clearly defined on initial examination and bidimensionally measurable
Ascites and pleural effusions are not considered measurable disease
Must not be eligible for a higher priority Gynecologic Oncology Group protocol
Must have received one, and only one, prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease
Initial treatment may include high-dose therapy, consolidation, or extended therapy administered after surgical or nonsurgical assessment
If no prior paclitaxel, a second regimen containing paclitaxel allowed
Platinum-resistant or refractory (i.e., treatment-free interval after platinum-based therapy of less than 6 months or progressed during platinum-based therapy)
PATIENT CHARACTERISTICS:
Age:
Not specified
Performance status:
GOG 0-2
Life expectancy:
Not specified
Hematopoietic:
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hepatic:
Bilirubin no greater than 1.5 times upper limit of normal (ULN)
SGOT no greater than 2.5 times ULN
Alkaline phosphatase no greater than 2.5 times ULN
Renal:
Creatinine no greater than 1.5 times ULN
Other:
Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception
No active infection requiring antibiotics
No other malignancy within the past 5 years except nonmelanoma skin cancer
Sensory and motor neuropathy no greater than grade 1
PRIOR CONCURRENT THERAPY:
Biologic therapy:
At least 3 weeks since prior biologic or immunologic therapy for ovarian or peritoneal cancer
Chemotherapy:
See Disease Characteristics
No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens
No prior gemcitabine
At least 3 weeks since prior chemotherapy for ovarian or peritoneal cancer and recovered
Endocrine therapy:
At least 1 week since prior hormonal therapy for ovarian or peritoneal cancer
Concurrent continuation of hormonal replacement therapy allowed
Radiotherapy:
At least 3 weeks since prior radiotherapy for ovarian or peritoneal cancer and recovered
No prior radiotherapy to only site of measurable disease
No prior radiotherapy to more than 25% of bone marrow
Surgery:
See Disease Characteristics
At least 3 weeks since prior surgery for ovarian or peritoneal cancer and recovered
Other:
At least 3 weeks since other prior therapy for ovarian or peritoneal cancer
No prior cancer treatment that would preclude study
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There are 31 Locations for this study
Los Gatos California, 95032, United States
Tampa Florida, 33612, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46285, United States
Iowa City Iowa, 52242, United States
Bethesda Maryland, 20892, United States
Boston Massachusetts, 02111, United States
Jackson Mississippi, 39216, United States
Columbia Missouri, 65203, United States
Camden New Jersey, 08103, United States
Brooklyn New York, 11203, United States
Buffalo New York, 14263, United States
Stony Brook New York, 11794, United States
Chapel Hill North Carolina, 27599, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27157, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Oklahoma City Oklahoma, 73190, United States
Abington Pennsylvania, 19001, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19111, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75390, United States
Galveston Texas, 77555, United States
Houston Texas, 77030, United States
Madison Wisconsin, 53792, United States
Oslo , N-031, Norway
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