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Home > "G" Clinical Trials Conditions > Gemcitabine in Treating Patients With Persistent or Recurrent Cancer of the Cervix

Gemcitabine in Treating Patients With Persistent or Recurrent Cancer of the Cervix



Gemcitabine in Treating Patients With Persistent or Recurrent Cancer of the Cervix

For Condition: cervical adenocarcinoma,cervical adenosquamous cell carcinoma,recurrent cervical cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Gynecologic Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who have persistent or recurrent cancer of the cervix .
Details: OBJECTIVES: I. Determine the antitumor activity of gemcitabine in patients with persistent or recurrent nonsquamous cell carcinoma of the cervix who failed higher priority treatment protocols. II. Determine the toxicity of this regimen in these patients. PROTOCOL OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Courses repeat every 4 weeks 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: Approximately 15-37 patients will be accrued for this study within 1 year.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of persistent or recurrent nonsquamous cell carcinoma of the cervix that has failed local therapeutic measures and is considered incurable; Eligible subtypes: Adenocarcinoma; Adenosquamous carcinoma; Undifferentiated carcinoma; Must have documented disease progression; Histologic confirmation of original primary tumor required - Bidimensionally measurable disease - Ineligible for higher priority GOG protocol --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent filgrastim (G-CSF) - Chemotherapy: No prior gemcitabine; At least 3 weeks since other prior chemotherapy for cervical cancer and recovered; No more than 1 prior chemotherapy regimen (single or combination cytotoxic therapy) - Endocrine therapy: Not specified - Radiotherapy: At least 3 weeks since prior radiotherapy for cervical cancer and recovered - Surgery: At least 3 weeks since prior surgery for cervical cancer and recovered - Other: No prior cancer treatment that would preclude study --Patient Characteristics-- - Age: 18 and over - Performance status: GOG 0-2 - Life expectancy: Not specified - Hematopoietic: Platelet count at least 100,000/mm3; Granulocyte count at least 1,500/mm3 - Hepatic: Bilirubin no greater than 1.5 times normal SGOT and alkaline phosphatase no greater than 3 times normal - Renal: Creatinine no greater than 1.5 mg/dL - Other: No significant infection; Not pregnant; Fertile patients must use effective contraception; No other invasive malignancy within the past 5 years except nonmelanomatous skin cancer
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
RussellSchilder,  Study Chair,  Gynecologic Oncology Group

Lineberger Comprehensive Cancer Center, UNC
Chapel Hill,  North Carolina,  27599-7295
United States
 

Fox Chase Cancer Center
Philadelphia,  Pennsylvania,  19111
United States
 

Holden Comprehensive Cancer Center at The University of Iowa
Iowa City,  Iowa,  52242-1009
United States
 

University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham,  Alabama,  35294-3300
United States
 

Tacoma General Hospital
Tacoma,  Washington,  98405
United States
 

Jonsson Comprehensive Cancer Center, UCLA
Los Angeles,  California,  90095-1781
United States
 

Rush-Presbyterian-St. Luke's Medical Center
Chicago,  Illinois,  60612
United States
 

Washington University School of Medicine
St. Louis,  Missouri,  63110
United States
 

Barrett Cancer Center, The University Hospital
Cincinnati,  Ohio,  45267-0502
United States
 

Chao Family Comprehensive Cancer Center
Orange,  California,  92868
United States
 

Ireland Cancer Center
Cleveland,  Ohio,  44106-5065
United States
 

Cancer Center at the University of Virginia
Charlottesville,  Virginia,  22908
United States
 

University of Chicago Cancer Research Center
Chicago,  Illinois,  60637-1470
United States
 

Cleveland Clinic Taussig Cancer Center
Cleveland,  Ohio,  44195
United States
 

Tufts University School of Medicine
Boston,  Massachusetts,  02111
United States
 

Cancer Center of Albany Medical Center
Albany,  New York,  12208
United States
 

Ellis Fischel Cancer Center
Columbia,  Missouri,  65203
United States
 

Milton S. Hershey Medical Center
Hershey,  Pennsylvania,  17033-0850
United States
 

Medical University of South Carolina
Charleston,  South Carolina,  29425-0721
United States
 

Duke Comprehensive Cancer Center
Durham,  North Carolina,  27710
United States
 

Arthur G. James Cancer Hospital - Ohio State University
Columbus,  Ohio,  43210-1240
United States
 

Tom Baker Cancer Center - Calgary
Calgary,  Alberta,  T2N 4N2
Canada
 

Fletcher Allen Health Care - Medical Center Campus
Burlington,  Vermont,  05401
United States
 

University of Mississippi Medical Center
Jackson,  Mississippi,  39216-4505
United States
 

Brookview Research, Inc.
Nashville,  Tennessee,  37203
United States
 

Abington Memorial Hospital
Abington,  Pennsylvania,  19001
United States
 

Cooper Hospital/University Medical Center
Camden,  New Jersey,  08103
United States
 

Simmons Cancer Center - Dallas
Dallas,  Texas,  75235-9154
United States
 

State University of New York Health Science Center at Brooklyn
Brooklyn,  New York,  11203
United States
 

Indiana University Cancer Center
Indianapolis,  Indiana,  46202-5289
United States
 

Barbara Ann Karmanos Cancer Institute
Detroit,  Michigan,  48201-1379
United States
 

University of Oklahoma College of Medicine
Oklahoma City,  Oklahoma,  73190
United States
 

Albert B. Chandler Medical Center, University of Kentucky
Lexington,  Kentucky,  40536-0084
United States
 

University of Pennsylvania Cancer Center
Philadelphia,  Pennsylvania,  19104-4283
United States
 

Community Hospital of Los Gatos
Los Gatos,  California,  95032
United States
 

Ellis Fischel Cancer Center - Columbia
Columbia,  Missouri,  65203
United States
 

Comprehensive Cancer Center at Wake Forest University
Winston Salem,  North Carolina,  27157-1082
United States
 

H. Lee Moffitt Cancer Center and Research Institute
Tampa,  Florida,  33612-9497
United States
 

Walter Reed Army Medical Center
Washington D.C.,  District of Columbia,  20307-5000
United States
 


Additional Information:
Study ID Numbers:
  CDR0000068144;  GOG-0128F
Study Start Date: September 2000
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006224

Other Cervical Adenocarcinoma Studies:
1. Gemcitabine in Treating Patients With Persistent or Recurrent Cancer of the Cervix

2. Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix

3. Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix

4. Capecitabine in Treating Patients With Persistent or Recurrent Cervical Cancer

5. EF5 to Detect Tumor Hypoxia in Patients With Stage IIB, Stage IIIB, or Stage IVA Cervical Cancer

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