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
NCT ID: NCT00006028
Last Updated: 2013-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2001-01-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
Interventions
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cisplatin
gemcitabine hydrochloride
Eligibility Criteria
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Inclusion Criteria
* 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
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Principal Investigators
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Cheryl A. Brewer, MD
Role: STUDY_CHAIR
University of Illinois College of Medicine at Peoria
Locations
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Community Hospital of Los Gatos
Los Gatos, California, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Ellis Fischel Cancer Center
Indianapolis, Indiana, United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States
Tuft-New England Medical Center
Boston, Massachusetts, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
Cooper Hospital/University Medical Center
Camden, New Jersey, United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Brookview Research, Inc.
Nashville, Tennessee, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
CCOP - M.D. Anderson Research Base
Houston, Texas, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Norwegian Radium Hospital
Oslo, , Norway
Countries
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References
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Brewer CA, Blessing JA, Nagourney RA, Morgan M, Hanjani P. Cisplatin plus gemcitabine in platinum-refractory ovarian or primary peritoneal cancer: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2006 Nov;103(2):446-50. doi: 10.1016/j.ygyno.2006.03.018. Epub 2006 Apr 27.
Other Identifiers
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GOG-0126L
Identifier Type: -
Identifier Source: secondary_id
CDR0000068041
Identifier Type: -
Identifier Source: org_study_id
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