RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining cisplatin with gemcitabine in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Clinique Sainte Catherine
Avignon, France
C.H.G. Beauvais
Beauvais, France
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Centre Hospitalier Departmental Felix Guyon
Bellepierre, France
Centre Hospitalier General
Brivé, France
Centre Hospitalier Emile Roux
Eaubonne, France
Centre Jean Bernard
Le Mans, France
C.H. Mans
Le Mans, France
Hopital Perpetuel Secours
Levallois-Perret, France
Clinique St. Faron
Mareuil-lès-Meaux, France
Clinique de Docteur Terrioux
Meaux, France
...and 11 more locations