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.

Condition	Treatment or Intervention	Phase
Anemia Cervical Cancer Drug Toxicity Quality of Life radiation toxicity	Drug: cisplatin  Drug: epoetin alfa  Procedure: biological response modifier therapy  Procedure: brachytherapy  Procedure: chemoprotection  Procedure: chemotherapy  Procedure: colony-stimulating factor therapy  Procedure: complications of therapy assessment/management  Procedure: cytokine therapy  Procedure: hematologic toxicity attenuation  Procedure: quality-of-life assessment  Procedure: radiation therapy  Procedure: radioprotection  Procedure: supportive care/therapy	Phase III

Further Study 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.

Genders Eligible for Study:  Both

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

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1740,  United States
Colorado
      University of Colorado Cancer Center, Denver,  Colorado,  80010,  United States
District of Columbia
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5001,  United States
Hawaii
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States
Iowa
      Holden Comprehensive Cancer Center, Iowa City,  Iowa,  52242-1009,  United States
Kentucky
      Albert B. Chandler Medical Center, University of Kentucky, Lexington,  Kentucky,  40536-0084,  United States
Maryland
      Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda,  Maryland,  20892-1182,  United States
Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States
New Jersey
      Cooper University Hospital, Camden,  New Jersey,  08103-1489,  United States
New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States
      State University of New York Health Science Center at Brooklyn, Brooklyn,  New York,  11203,  United States
      State University of New York Health Sciences Center - Stony Brook, Stony Brook,  New York,  11794-8091,  United States
North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1065,  United States
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States
      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States
Ohio
      Barrett Cancer Center, Cincinnati,  Ohio,  45267-0526,  United States
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States
Oklahoma
      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73190,  United States
Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001-3788,  United States
      Abramson Cancer Center of the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104-4283,  United States
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States
South Carolina
      Medical University of South Carolina, Charleston,  South Carolina,  29425-2233,  United States
Tennessee
      Gynecologic Oncology of Middle Tennessee, Nashville,  Tennessee,  37203,  United States
Texas
      CCOP - M.D. Anderson Research Base, Houston,  Texas,  77030-4009,  United States
      University of Texas Medical Branch, Galveston,  Texas,  77555-0587,  United States
Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109-1024,  United States
      Tacoma General Hospital, Tacoma,  Washington,  98405,  United States
Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada
Canada, British Columbia
      British Columbia Cancer Agency - Fraser Valley Cancer Centre, Surrey,  British Columbia,  V3V 1Z2,  Canada
      British Columbia Cancer Agency - Vancouver Island Cancer Centre, Victoria,  British Columbia,  V8R 6V5,  Canada
      British Columbia Cancer Agency, Vancouver,  British Columbia,  V5Z 4E6,  Canada
Canada, New Brunswick
      Saint John Regional Hospital, Saint John,  New Brunswick,  E2L 4L2,  Canada
Canada, Nova Scotia
      Nova Scotia Cancer Centre, Halifax,  Nova Scotia,  B3H 1V7,  Canada
Canada, Ontario
      Cancer Care Ontario-Hamilton Regional Cancer Centre, Hamilton,  Ontario,  L8V 5C2,  Canada
      Cancer Care Ontario-London Regional Cancer Centre, London,  Ontario,  N6A 4L6,  Canada
      Kingston Regional Cancer Centre, Kingston,  Ontario,  K7L 5P9,  Canada
      Toronto Sunnybrook Regional Cancer Centre, Toronto,  Ontario,  M4N 3M5,  Canada
Canada, Quebec
      Centre Hospitalier Universitaire de Quebec, Quebec City,  Quebec,  G1R 2J6,  Canada
      CHUS-Hopital Fleurimont, Fleurimont,  Quebec,  J1H 5N4,  Canada
      Hopital Notre- Dame du CHUM, Montreal,  Quebec,  H4L 2M1,  Canada
      McGill University, Montreal,  Quebec,  H2W 1S6,  Canada
Norway
      Norwegian Radium Hospital, Oslo,  N-0310,  Norway
United Kingdom, England
      University of Birmingham, Birmingham,  England,  B15 2TT,  United Kingdom

Study chairs or principal investigators

Gillian Monica Thomas, BSc, MD, FRCPC,  Study Chair,  Glaxosmithkline Inc.   
Peter S. Craighead, MD,  Study Chair,  Tom Baker Cancer Center - Calgary   

Study ID Numbers:  CDR0000068641; GOG-0191; CAN-NCIC-CX4
Record last reviewed:  October 2003
Last Updated:  October 13, 2004
Record first received:  June 6, 2001
ClinicalTrials.gov Identifier:  NCT00017004
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08