Lung Cancer Clinical Trial
Chemotherapy and Radiation Therapy With or Without Epoetin Alfa in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may stimulate red blood cell production and prevent or treat anemia in patients who are undergoing radiation therapy and chemotherapy. It is not yet known if chemotherapy combined with radiation therapy is more effective with or without epoetin alfa in treating non-small cell lung cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of chemotherapy combined with radiation therapy with or without epoetin alfa in treating patients who have stage IIIA or stage IIIB non-small cell lung cancer.
Full Description
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.
Eligibility Criteria
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
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There is 1 Location for this study
Winston-Salem North Carolina, 27157, United States
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