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Spots Global Cancer Trial Database for Gemcitabine and Cisplatin in Treating Patients With Refractory or Recurrent Cancer of the Cervix

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Trial Identification

Brief Title: Gemcitabine and Cisplatin in Treating Patients With Refractory or Recurrent Cancer of the Cervix

Official Title: A Phase II Evaluation Of Gemcitabine And Cisplatin In Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix

Study ID: NCT00006482

Conditions

Cervical Cancer

Study Description

Brief 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 combining gemcitabine and cisplatin in treating patients who have refractory or recurrent cancer of the cervix.

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.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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, 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

Contact Details

Name: Cheryl A. Brewer, MD

Affiliation: University of Illinois College of Medicine at Peoria

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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