Epoetin Beta in Treating Anemia in Patients With Cervical Cancer

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Epoetin beta may stimulate red blood cell production to prevent or control anemia in patients treated with chemotherapy and radiation therapy.

PURPOSE: Randomized phase IV trial to determine the effectiveness of epoetin beta in treating anemia in patients who are receiving cisplatin and radiation therapy for stage IIB, stage III, or stage IVA cervical cancer.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AGO Study Group
• Treatments: Cisplatin; Epoetin Alfa

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage IIB, III, or IVA cervical cancer

• No chorion carcinoma or neuroendocrine small cell carcinoma

• Previously untreated disease

• Must be scheduled to undergo radiotherapy and receive cisplatin as primary therapy

• Hemoglobin 8.0-13.0 g/dL

• No relevant acute bleeding within the past 3 months, including anemia caused by gross bleeding from tumor

• No distant metastasis

• No positive para-aortic lymph nodes

PATIENT CHARACTERISTICS:

Age

• Over 18

Performance status

• WHO 0-2

Life expectancy

• At least 3 months

Hematopoietic

• See Disease Characteristics

• WBC greater than 3,000/mm3

• Platelet count greater than 100,000/mm3

• No hemolytic anemia

• No transferrin saturation less than 20% that cannot be treated with IV iron

• No hemoglobinopathies (i.e., sickle cell disease or thalassemia of all types)

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• Transaminases no greater than 2.5 times ULN

• Alkaline phosphatase no greater than 2.5 times ULN

Renal

• Creatinine clearance greater than 60 mL/min

Cardiovascular

• No chronic heart failure

• No New York Heart Association class II-IV heart disease

• No uncontrolled arterial hypertension (systolic blood pressure at least 170 mmHg, diastolic blood pressure at least 100 mmHg)

• No prior deep vein thrombosis

• No thrombocytosis

Other

• No vitamin B12 deficiency

• No folic acid deficiency

• No newly diagnosed (unstable) epilepsy

• No acute infection

• No other malignancy within the past 5 years except basal cell carcinoma in situ

• No known peripheral neuropathy or moto-sensory neurotoxicity grade 2 or greater

• No impaired hearing grade 2 or greater

• No hypersensitivity to benzyl alcohol, benzoic acid, benzalkonium chloride, or any excipients of cisplatin preparations

• Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy

• At least 3 months since prior epoetins or related compounds

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

• No prior radiotherapy for cervical cancer

Surgery

• Not specified

Other

• At least 30 days since prior investigational drugs

• No prior systemic antineoplastic therapy for cervical cancer

• No other concurrent investigational drugs