Radiation Therapy With or Without Epoetin Alfa in Treating Anemic Patients With Head and Neck Cancer

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may stimulate red blood cell production and treat anemia in patients with head and neck cancer. It is not yet known whether receiving radiation therapy with epoetin alfa is more effective than radiation therapy alone in treating anemic patients with head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without epoetin alfa in treating anemic patients who have head and neck cancer.

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

Details

• Lead Sponsor: Radiation Therapy Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Epoetin Alfa

Criteria

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