Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00006116
- Lead Sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Centre Hospitalier Departmental Felix Guyon
🇫🇷Bellepierre, France
Centre Hospitalier General
🇫🇷Brive, France
Hopital Saint Antoine
🇫🇷Paris, France
Hopital Claude Gallien
🇫🇷Quincy Sous Senart, France
Clinique les Bleuets
🇫🇷Reims, France
Hopital Tenon
🇫🇷Paris, France
Centre du Rouget
🇫🇷Sarcelles, France
Centre Rene Huguenin
🇫🇷Saint Cloud, France
C.H. Mans
🇫🇷Le Mans, France
Clinique Hartmann
🇫🇷Neuilly sur Seine, France
Clinique Sainte Catherine
🇫🇷Avignon, France
C.H.G. Beauvais
🇫🇷Beauvais, France
Centre Jean Bernard
🇫🇷Le Mans, France
Clinique St. Faron
🇫🇷Mareuil Les Meaux, France
Clinique de Docteur Terrioux
🇫🇷Meaux, France
Groupe Medical Saint Remy
🇫🇷Reims, France
Polyclinique De Courlancy
🇫🇷Reims, France
Hopital Perpetuel Secours
🇫🇷Levallois-Perret, France
Centre Hospitalier Emile Roux
🇫🇷Eaubonne, France
American Hospital of Paris
🇫🇷Neuilly Sur Seine, France
Clinique Du Mont Louis
🇫🇷Paris, France