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. Combining chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have limited-stage small cell lung cancer.
OBJECTIVES: * Determine the complete and overall response rates in patients with limited stage small cell lung cancer treated with induction chemotherapy comprising paclitaxel, topotecan, and etoposide followed by consolidation chemoradiotherapy. * Determine the toxicity of this regimen in these patients. * Determine the overall and failure-free survival of patients treated with this regimen. * Determine the overall (partial and complete) response rate in patients treated with this induction chemotherapy regimen. OUTLINE: This is a multicenter study. * Induction therapy: Patients receive paclitaxel IV over 3 hours on days 1 and 22, oral topotecan on days 2-4 and 23-25, and oral etoposide on days 5-7 and 26-28. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on days 8 and 29 and continuing until blood counts recover. * Consolidation therapy: Patients receive carboplatin IV over 1 hour on days 43, 64, and 85 and etoposide IV over 1 hour on days 43-45, 64-66, and 85-87. Patients undergo radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks. Patients with rapid disease progression discontinue study therapy. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years. PROJECTED ACCRUAL: A total of 25-60 patients will be accrued for this study within 10 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
overall response rate
Time frame: up to 5 years
failure-free survival
Time frame: up to 5 years
overall survival
Time frame: up to 5 years
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Veterans Affairs Medical Center - Birmingham
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