Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00075517
- Lead Sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Brief Summary
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.
- Detailed Description
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.
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 Response rate
- Secondary Outcome Measures
Name Time Method Progression-free survival Overall survival Tolerability Quality of life
Trial Locations
- Locations (12)
Hopital Avicenne
🇫🇷Bobigny, France
Hopital Paul Brousse
🇫🇷Villejuif, France
Hopital Perpetuel Secours
🇫🇷Levallois-Perret, France
Clinique de Docteur Terrioux
🇫🇷Meaux, France
Centre Jean Bernard
🇫🇷Le Mans, France
American Hospital of Paris
🇫🇷Neuilly Sur Seine, France
Centre Rene Huguenin
🇫🇷Saint Cloud, France
Centre de Radiotherapie et Oncologie Saint-Faron
🇫🇷Mareuil Les Meaux, France
Hopital Tenon
🇫🇷Paris, France
Clinique les Bleuets
🇫🇷Reims, France
Polyclinique De Courlancy
🇫🇷Reims, France
Clinique Francois
🇫🇷Saint-Dizier, France