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

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary Determine whether epoetin alfa given during definitive radiotherapy or chemoradiotherapy improves the local-regional control rate in anemic patients with squamous cell carcinoma of the head and neck. Secondary Determine whether this drug improves survival in this patient population. Identify patterns in first failure in these patients. Determine whether there is a significant increase in hemoglobin level between the baseline value and the value at 28 days after starting epoetin alfa in these patients. Assess the toxicity of this regimen in these patients. OUTLINE: This is a randomized study. Patients are stratified according to stage (I/II vs III/IV without chemotherapy vs III/IV with chemotherapy), pretreatment hemoglobin level (9.0 to less than 11.5 g/dL vs 11.5 to 13.5 g/dL), and gender. Patients are randomized to one of two treatment arms. Arm I: Patients with stage I or II disease undergo radiotherapy once daily for 6-7 weeks. Patients with stage III or IV disease undergo radiotherapy once daily for 3.5 weeks and then twice daily (6 hours apart) for 2.5 weeks for a total of 6 weeks. Arm II: Patients undergo radiotherapy as in arm I. Beginning 7-10 days before radiotherapy, patients receive epoetin alfa subcutaneously once weekly until the end of radiotherapy. Patients with stage III/IV disease may receive concurrent cisplatin IV over 1-2 hours on days 1 and 22 of radiotherapy. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 372 patients (186 per arm) will be accrued for this study within 3.5 years.

Official Title
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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

Conditions
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Anemia, Head and Neck Cancer

Intervention / Treatment
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* Biological: epoetin alfa
* Drug: cisplatin
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: epoetin alfa|nan|
|Drug: cisplatin|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anemia, stage I squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage I squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage I squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx