Intensive Chemotherapy With Peripheral Blood Stem Cell Support for Small Cell Lung Cancer
OBJECTIVES: I. Determine the feasibility of the administration of intensive chemotherapy
with ifosfamide, carboplatin, and etoposide followed by peripheral blood stem cell support
in patients with small cell lung cancer. II. Determine the rate and duration of response in
these patients after this treatment. III. Determine the progression free and overall
survival of these patients.
OUTLINE: This is an open label, multicenter study. Patients receive 4 courses of intensive
chemotherapy consisting of ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day
1 and etoposide IV over 1 hour on days 1 and 2. Filgrastim (G-CSF) is administered
subcutaneously beginning on day 2 and continuing until blood cell counts recover. Courses
repeat every 14 days. Peripheral blood stem cells (PBSC) are collected after course 1. PBSC
are reinfused on day 3 of courses 2 and 3. Patients who experience a complete response
receive prophylactic cerebral irradiation on day 71. Patients are followed every 2 months
for 5 years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 18 months.
Interventional
Primary Purpose: Treatment
Veronique N. Trillet-Lenoir, MD
Study Chair
Centre Hospitalier Lyon Sud
United States: Federal Government
CDR0000067023
NCT00003860
September 1998
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