Gemcitabine and Cisplatin in Treating Patients With Refractory or Recurrent Cancer of the Cervix
NCT ID: NCT00006482
Last Updated: 2013-04-11
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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TERMINATED
PHASE2
INTERVENTIONAL
2000-10-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and cisplatin in treating patients who have refractory or recurrent cancer of the cervix.
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Detailed Description
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* Determine the antitumor activity of gemcitabine and cisplatin in patients with refractory or recurrent squamous cell carcinoma of the cervix.
* Determine the nature and degree of toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive cisplatin IV and gemcitabine IV over 1 hour on days 1 and 8. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 28-69 patients will be accrued for this study.
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
Age:
* Not specified
Performance status:
* GOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Platelet count at least lower limit of normal
* Absolute neutrophil count at least 1,500/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times normal
* SGOT and alkaline phosphatase no greater than 3 times normal
Renal:
* Creatinine no greater than 2.0 mg/dL
Other:
* Not pregnant
* Fertile patients must use effective contraception
* No significant infection
* No other malignancies within past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 3 weeks since prior biologic therapy for cervical cancer
Chemotherapy:
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy for cervical cancer and recovered
* No prior gemcitabine
Endocrine therapy:
* At least 3 weeks since prior endocrine therapy for cervical cancer
Radiotherapy:
* At least 3 weeks since prior radiotherapy for cervical cancer and recovered
* No prior radiotherapy to more than 25% of marrow-bearing areas
Surgery:
* At least 3 weeks since prior surgery for cervical cancer and recovered
Other:
* No concurrent amifostine or other protective reagents
* No prior anticancer therapy that contraindicates 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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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Rational Therapeutics Inc.
Long Beach, California, United States
Community Hospital of Los Gatos
Los Gatos, California, United States
Chao Family Comprehensive Cancer Center
Orange, California, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 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 Illinois College of Medicine at Peoria
Peoria, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States
Tufts University School of Medicine
Boston, Massachusetts, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Cooper Hospital/University Medical Center
Camden, New Jersey, United States
Cancer Center of Albany Medical Center
Albany, New York, 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
Schneider Children's Hospital at North Shore
Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, 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
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, 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
Simmons Cancer Center - Dallas
Dallas, Texas, United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States
Tacoma General Hospital
Tacoma, Washington, United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada
Countries
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References
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Brewer CA, Blessing JA, Nagourney RA, McMeekin DS, Lele S, Zweizig SL. Cisplatin plus gemcitabine in previously treated squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2006 Feb;100(2):385-8. doi: 10.1016/j.ygyno.2005.09.009. Epub 2005 Nov 4.
Other Identifiers
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GOG-0127Q
Identifier Type: -
Identifier Source: secondary_id
CDR0000068313
Identifier Type: -
Identifier Source: org_study_id
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