Lung Cancer Clinical Trial
Official title:
Topotecan/Paclitaxel Induction Followed by Consolidation Chemoradiotherapy for Limited Stage Small Cell Lung Cancer: A Phase II Study
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 more than one drug and giving them before and with radiation therapy may be
an effective treatment for limited-stage small cell lung cancer.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in
treating patients who have limited-stage small cell lung cancer.
OBJECTIVES: I. Determine the complete response rate to 2 courses of paclitaxel and topotecan
followed by consolidation chemoradiotherapy in patients with limited stage small cell lung
cancer. II. Determine the toxic effects of this regimen in this patient population. III.
Describe the pattern of relapse, documenting carefully the location of relapse with respect
to the original disease volume and the radiation treatment field in these patients. IV.
Determine the overall and failure free survival of these patients.
OUTLINE: Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 1.
Filgrastim (G-CSF) is administered subcutaneously every day starting on day 6 until blood
counts recover. The course is repeated once beginning on day 22. After restaging, patients
begin thoracic radiotherapy daily, five days per week, for 6-7 weeks. On the same day that
radiotherapy begins, patients receive carboplatin IV over 1 hour (day 43) and etoposide IV
over 1 hour daily for 3 days (days 43-45). The consolidation chemotherapy is repeated every
21 days for a total of 3 courses. Patients with stable or responding disease undergo
prophylactic cranial irradiation. Patients are followed at least every 3 months for 2 years,
every 6 months for 3 years, and then at least every year.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 15-18
months.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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