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Radiation Therapy and Cisplatin With or Without Epoetin Alfa in Treating Patients With Cervical Cancer and Anemia

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NCIC Clinical Trials Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00017004
First received: June 6, 2001
Last updated: January 7, 2012
Last verified: May 2004
History of Changes

June 6, 2001
January 7, 2012
August 2001
January 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00017004 on ClinicalTrials.gov Archive Site
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Radiation Therapy and Cisplatin With or Without Epoetin Alfa in Treating Patients With Cervical Cancer and Anemia
Phase III Trial to Evaluate the Efficacy of Maintaining Hemoglobin Levels Above 120 G/L With Erythropoietin Versus Above 100 G/L Without Erythropoietin in Anemic Patients Receiving Concurrent Radiation and Cisplatin for Cervical Cancer

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.

OBJECTIVES:

  • Assess the efficacy of raising and maintaining hemoglobin (Hgb) levels above 12.0 g/dL with epoetin alfa vs maintaining Hgb levels above 10.0 g/dL 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.
Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Supportive Care
  • Anemia
  • Cervical Cancer
  • Drug/Agent Toxicity by Tissue/Organ
  • Radiation Toxicity
  • Biological: epoetin alfa
  • Drug: cisplatin
  • Procedure: quality-of-life assessment
  • Radiation: brachytherapy
  • Radiation: radiation therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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January 2010   (final data collection date for primary outcome measure)

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 14 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

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 participation
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • No history of hypersensitivity to epoetin alfa or human albumin
  • No diagnosis of vitamin B_12 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
Female
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No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Norway,   United Kingdom
 
NCT00017004
CDR0000068641, GOG-0191, CAN-NCIC-CX4
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Gynecologic Oncology Group
  • National Cancer Institute (NCI)
  • NCIC Clinical Trials Group
Study Chair: Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon) Odette Cancer Centre at Sunnybrook
Study Chair: Peter S. Craighead, MD Tom Baker Cancer Centre - Calgary
National Cancer Institute (NCI)
May 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP