First Line Treatment of Stage IIIb/IV Non Small Cell (NSC) Lung Cancer With a Bimonthly Administration of a Combination of Cisplatin-Gemcitabine
OBJECTIVES: I. Determine the efficacy of the combination of cisplatin and gemcitabine in
terms of response rate and progression free survival in patients with stage IIIB or IV
non-small cell lung cancer. II. Evaluate this treatment regimen in terms of toxicity and
quality of life in these patients.
OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes and
cisplatin IV over 1 hour every 2 weeks for 6 courses in the absence of disease progression
or unacceptable toxicity. Patients with no disease progression following 6 courses of
therapy receive an additional 6 courses of therapy. Quality of life is assessed prior to
each course and then every 3 months. Patients are followed every 3 months until death.
PROJECTED ACCRUAL: A total of 37-83 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Philippe Terrioux, MD
Study Chair
Clinique de Docteur Terrioux
United States: Federal Government
CDR0000068129
NCT00006116
April 1999
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