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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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. Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have cervical cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborators: Canadian Cancer Trials Group; National Cancer Institute (NCI); NCIC Clinical Trials Group
• Treatments: Cisplatin; Epoetin Alfa

Criteria

Inclusion Criteria:

• 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

• Performance status - GOG 0-3

• See Disease Characteristics

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Bilirubin no greater than 1.5 times normal

• SGOT no greater than 3 times normal

• Alkaline phosphatase no greater than 3 times normal

• Creatinine no greater than 2.0 mg/dL

• No uncontrolled hypertension

• No history of thrombotic vascular events (e.g., deep vein thrombosis or myocardial infarction)

• No active hemolysis

• No history of pulmonary embolism

• 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

• See Disease Characteristics

• See Disease Characteristics