RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with inoperable stage IIIB or stage IV non-small cell lung cancer.
OBJECTIVES: Primary * Determine the response rate in patients with inoperable stage IIIB or IV non-small cell lung cancer treated with gemcitabine and docetaxel. Secondary * Determine the progression-free and overall survival of patients treated with this regimen. * Determine the tolerance profile of this regimen in these patients. * Determine the quality of life of patients treated with this regimen. OUTLINE: This is a nonrandomized, multicenter study. Patients receive docetaxel IV over 1 hour and gemcitabine IV over 2 hours on day 1. Treatment repeats every 15 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, after courses 6 and 12, and then every 3 months thereafter. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study within 18 months.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Hopital Avicenne
Bobigny, France
Centre Jean Bernard
Le Mans, France
Hopital Perpetuel Secours
Levallois-Perret, France
Response rate
Progression-free survival
Overall survival
Tolerability
Quality of life
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Centre de Radiotherapie et Oncologie Saint-Faron
Mareuil-lès-Meaux, France
Clinique de Docteur Terrioux
Meaux, France
American Hospital of Paris
Neuilly-sur-Seine, France
Hopital Tenon
Paris, France
Clinique les Bleuets
Reims, France
Polyclinique De Courlancy
Reims, France
Centre Rene Huguenin
Saint-Cloud, France
...and 2 more locations