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Home > "R" Clinical Trials Conditions > Radiation Therapy and Cisplatin With or Without Epoetin Alfa in Treating Patients With Cervical Cancer and Anemia  Radiation Therapy and Cisplatin With or Without Epoetin Alfa in Treating Patients With Cervical Cancer and Anemia
Radiation Therapy and Cisplatin With or Without Epoetin Alfa in Treating Patients With Cervical Cancer and Anemia
For Condition: Drug Toxicity,radiation toxicity,Cervical Cancer,Quality of Life,Anemia
Status: Suspended
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI),National Cancer Institute of Canada
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may stimulate red blood cell production to treat anemia in patients who have received chemotherapy and/or radiation therapy for cervical cancer. PURPOSE: Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have cervical cancer.
Details: OBJECTIVES: - Assess the efficacy of raising and maintaining hemoglobin (Hgb) levels above 120 g/L with epoetin alfa vs maintaining Hgb levels above 100 g/L without epoetin alfa on progression-free survival, overall survival, and local control in anemic patients with cervical cancer receiving concurrent radiotherapy and cisplatin. - Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized study. Patients are stratified according to stage (IIB vs IIIB vs IVA), method of brachytherapy (low-dose vs high-dose), and surgical staging of para-aortic nodes (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo radiotherapy comprising pelvic external beam radiotherapy daily five days a week for 5 weeks, followed by either 1 or 2 implants of low-dose rate intracavitary brachytherapy or 5 fractions of high-dose rate intracavitary brachytherapy, followed by 3-5 days of parametrial boost radiotherapy. Patients receive cisplatin IV concurrently with pelvic external beam radiotherapy on days 1, 8, 15, 22, 29, and once during the week of parametrial boost radiotherapy. - Arm II: Patients undergo radiotherapy and chemotherapy as in arm I. Additionally, patients receive epoetin alfa subcutaneously once weekly concurrently with radiotherapy and chemotherapy. Quality of life is assessed at baseline, during weeks 3 and 6, within 1 week of last brachytherapy, and every 3 months for 2 years. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 460 patients will be accrued for this study within 3.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix - Stage IIB, IIIB, or IVA - Primary, previously untreated disease - Hemoglobin less than 13 g/dL at presentation - Negative, non-suspicious para-aortic nodes determined by lymphangiogram, CT scan, MRI, or lymphadenectomy - Eligible for treatment with radical intent involving concurrent cisplatin and pelvic radiotherapy - No involvement of the lower third of vagina - No carcinoma of the cervical stump PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - GOG 0-3 Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics - 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 normal - SGOT no greater than 3 times normal - Alkaline phosphatase no greater than 3 times normal - Hemoglobin less than 130 g/L Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No uncontrolled hypertension - No history of thrombotic vascular events (e.g., deep vein thrombosis or myocardial infarction) - No active hemolysis Pulmonary: - No history of pulmonary embolism Other: - No septicemia or severe infection - No circumstances that would preclude study - No other invasive malignancy within the past 5 years except non-melanoma skin cancer - No history of hypersensitivity to epoetin alfa or human albumin - No diagnosis of vitamin B12 or folic acid deficiency - No recent (within the past 3 months) or uncontrolled seizure disorder - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PeterCraighead, Study Chair, Tom Baker Cancer Center - Calgary
CCOP - M.D. Anderson Research Base
Houston, Texas, 77030-4009
United States
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, V8R 6V5
Canada
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Hopital Notre- Dame du CHUM
Montreal, Quebec, H4L 2M1
Canada
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Norwegian Radium Hospital
Oslo, , N-0310
Norway
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11794-8091
United States
Barrett Cancer Center
Cincinnati, Ohio, 45267-0526
United States
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6
Canada
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9
Canada
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Gynecologic Oncology of Middle Tennessee
Nashville, Tennessee, 37203
United States
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Canada
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, G1R 2J6
Canada
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5001
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
United States
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Canada
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
CHUS-Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4
Canada
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1740
United States
Tacoma General Hospital
Tacoma, Washington, 98405
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0587
United States
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, L8V 5C2
Canada
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1065
United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001-3788
United States
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Canada
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
British Columbia Cancer Agency - Fraser Valley Cancer Centre
Surrey, British Columbia, V3V 1Z2
Canada
Medical University of South Carolina
Charleston, South Carolina, 29425-2233
United States
Cooper University Hospital
Camden, New Jersey, 08103-1489
United States
McGill University
Montreal, Quebec, H2W 1S6
Canada
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
University of Birmingham
Birmingham, England, B15 2TT
United Kingdom
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Additional Information:
Study ID Numbers: CDR0000068641; CAN-NCIC-CX4,GOG-0191
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017004
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3. Radiation Therapy, Combination Chemotherapy, and Amifostine Followed by Surgery to Remove the Esophagus in Treating Patients With Locally Advanced Cancer of the Esophagus
4. Paclitaxel, Folic Acid, and Lometrexol in Treating Patients With Locally Advanced or Metastatic Solid Tumors
5. Dexamethasone Followed by Denileukin Diftitox in Treating Patients With Persistent or Recurrent T-Cell Lymphoma
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Radiation Therapy and Cisplatin With or Without Epoetin Alfa in Treating Patients With Cervical Cancer and Anemia
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