- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006482
Gemcitabine and Cisplatin in Treating Patients With Refractory or Recurrent Cancer of the Cervix
A Phase II Evaluation Of Gemcitabine And Cisplatin In Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix
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 combining gemcitabine and cisplatin in treating patients who have refractory or recurrent cancer of the cervix.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- 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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Center - Calgary
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Alabama
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Birmingham, Alabama, United States, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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California
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Long Beach, California, United States, 90807
- Rational Therapeutics Inc.
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Los Gatos, California, United States, 95032
- Community Hospital of Los Gatos
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Orange, California, United States, 92868
- Chao Family Comprehensive Cancer Center
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District of Columbia
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Washington, District of Columbia, United States, 20307-5000
- Walter Reed Army Medical Center
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Florida
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Tampa, Florida, United States, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Illinois
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Chicago, Illinois, United States, 60612
- Rush-Presbyterian-St. Luke's Medical Center
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Peoria, Illinois, United States, 61603
- University of Illinois College of Medicine at Peoria
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Indiana
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Indianapolis, Indiana, United States, 46202-5289
- Indiana University Cancer Center
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Kentucky
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Lexington, Kentucky, United States, 40536-0084
- Albert B. Chandler Medical Center, University of Kentucky
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Tufts University School of Medicine
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Mississippi
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Jackson, Mississippi, United States, 39216-4505
- University of Mississippi Medical Center
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New Jersey
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Camden, New Jersey, United States, 08103
- Cooper Hospital/University Medical Center
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New York
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Albany, New York, United States, 12208
- Cancer Center of Albany Medical Center
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Brooklyn, New York, United States, 11203
- State University of New York Health Science Center at Brooklyn
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Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
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Manhasset, New York, United States, 11030
- Schneider Children's Hospital at North Shore
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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North Carolina
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Chapel Hill, North Carolina, United States, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, United States, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Cincinnati, Ohio, United States, 45267-0502
- Barrett Cancer Center, The University Hospital
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Taussig Cancer Center
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Cleveland, Ohio, United States, 44106-5065
- Ireland Cancer Center
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Columbus, Ohio, United States, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73190
- University of Oklahoma College of Medicine
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Pennsylvania
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Abington, Pennsylvania, United States, 19001
- Abington Memorial Hospital
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Hershey, Pennsylvania, United States, 17033-0850
- Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, United States, 19104-4283
- University of Pennsylvania Cancer Center
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Texas
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Dallas, Texas, United States, 75235-9154
- Simmons Cancer Center - Dallas
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Virginia
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Charlottesville, Virginia, United States, 22908
- Cancer Center at the University of Virginia
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Washington
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Tacoma, Washington, United States, 98405
- Tacoma General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically confirmed refractory or recurrent squamous cell carcinoma of the cervix that has failed local therapy and is considered incurable
Must have had 1 prior chemotherapy regimen for cervical cancer
- No more than 1 prior chemotherapy regimen (single or combination drug therapy), unless used as a radiosensitizer
- No prior chemotherapy for recurrent or persistent disease including retreatment with initial chemotherapy
- Bidimensionally measurable disease
- Ineligible for higher priority GOG protocol
PATIENT CHARACTERISTICS:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Cheryl A. Brewer, MD, University of Illinois College of Medicine at Peoria
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Uterine Cervical Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
Other Study ID Numbers
- CDR0000068313
- GOG-0127Q
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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