A Randomized Phase III Trial to Assess the Effect of Erythropoietin on Local-Regional Control in Anemic Patients Treated With Radiotherapy for Carcinoma of the Head and Neck

Fecha de inicio: 1 de junio de 2000

DISEASE CHARACTERISTICS: Histologically confirmed invasive squamous cell carcinoma of the head and neck, including carcinoma arising from the oral cavity, oropharynx, larynx, and hypopharynx Stage I-IV disease No distant metastases No carcinoma of the nasopharynx, nasal cavity/paranasal sinuses, or salivary glands No carcinoma in situ without an identifiable invasive component Plan for radiotherapy in continuous course Prior surgical exploration with gross residual disease remaining allowed Prior neck dissection with or without biopsy of primary tumor, but no radical surgery for primary tumor, allowed Anemia, defined as hemoglobin no greater than 13.5 g/dL for males and no greater than 12.5 g/dL for females (transfusion prior to study allowed) No severe anemia (i.e., hemoglobin less than 9.0 g/dL) No anemia confirmed to be due to causes other than chronic disease (e.g., iron deficiency anemia) Not entered on other RTOG head and neck protocols PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Stage III/IV patients receiving concurrent cisplatin: Absolute neutrophil count at least 2,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Not specified Renal: Stage III/IV patients receiving concurrent cisplatin: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 50 mL/min Cardiovascular: No malignant or poorly controlled hypertension (e.g., symptomatic hypertension or diastolic blood pressure of 100 mm Hg or greater despite antihypertensive medication) No unstable angina or other poorly controlled cardiac disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception If stage III or IV disease is present, willing to come for twice daily radiotherapy for the last 2.5 weeks of therapy No active infection requiring IV antibiotics No unexplained fever No AIDS or other history of congenital or acquired immunodeficiency No other malignancies within the past 3 years except carcinoma in situ or nonmelanomatous skin cancer No known hypersensitivity to mammalian cell-derived products or to human albumin No acute/subacute illness that would make the need for transfusion likely PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since other prior cytokine therapy (e.g., filgrastim [G-CSF], interleukins, or interferons) No prior epoetin alfa No other concurrent cytokine therapy Chemotherapy: No prior chemotherapy Concurrent cisplatin, paclitaxel/cisplatin, or paclitaxel/carboplatin for patients with stage III/IV disease is allowed Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to the head and neck Surgery: See Disease Characteristics Other: No concurrent amifostine No concurrent transfusion