Chemotherapy and Radiation Therapy With or Without Epoetin Alfa in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer

OBJECTIVES:

• Determine the efficacy of epoetin alfa in maintaining hemoglobin levels in patients with stage IIIA or IIIB non-small cell lung cancer when treated with chemoradiotherapy.
• Compare the time to local and systemic progression in patients receiving chemoradiotherapy with or without epoetin alfa.
• Compare tumor response rate and overall survival in patients treated with these regimens.
• Compare the toxicity of these regimens in these patients.
• Compare quality of life in patients treated with these regimens.
• Compare the number of transfusions in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Karnofsky performance status (90-100% vs 60-80%), weight loss (no more than 5% vs 6-10%), and baseline hemoglobin (women 11.0-12.4 g/dL and men 11.0-13.4 g/dL vs women 12.5-15.0 g/dL and men 13.5-15.0 g/dL). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Beginning 7-10 days before the start of chemoradiotherapy, patients receive epoetin alfa subcutaneously once weekly for 8 weeks. Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once weekly for 7 weeks. Patients undergo radiotherapy 5 days a week for 7 weeks for a total of 33 treatments. Treatment continues in the absence of disease progression or unacceptable toxicity.
• Arm II: Patients receive paclitaxel, carboplatin, and radiotherapy as in arm I. Quality of life is assessed at baseline, at completion of chemoradiotherapy, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 202-232 patients (101-116 per treatment arm) will be accrued for this study within 1.7-2 years.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed stage IIIA or IIIB non-small cell lung cancer (NSCLC)

• Squamous cell carcinoma
• Adenocarcinoma (including bronchoalveolar cell)
• Large cell anaplastic carcinoma (including giant and clear cell carcinomas)

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm3
• Platelet count at least 100,000/mm3
• Hemoglobin 11.0-15 g/dL
• If hemoglobin is 11.0-11.9 g/dL then the following lab values are required:

• Iron greater than 60 mcg/mL
• Transferrin saturation greater than 20%
• Ferritin at least 100 mg/mL
• Iron binding capacity less than 400 mcg/dL
• RBC folate normal
• B12 normal

Hepatic:

• Bilirubin less than 1.5 mg/dL
• AST less than 2 times upper limit of normal

Renal:

• Creatinine clearance at least 20 mL/min

Cardiovascular:

• No uncontrolled hypertension

Pulmonary:

• FEV1 at least 0.8 L

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No known hypersensitivity to mammalian cell-derived products or human albumin
• No other concurrent or prior malignancy within the past 2 years except non- melanoma skin cancers

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 30 days since prior transfusion
• No prior epoetin alfa or experimental forms of epoetin alfa

Chemotherapy:

• No prior chemotherapy for NSCLC

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy for NSCLC

Surgery:

• At least 2 weeks since prior thoracotomy

Other:

• No concurrent therapy for iron, folate, or B12 deficiency
• No other concurrent anti-cancer therapy