Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Recruitment status was Active, not recruiting
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study Of Gemcitabine And Docetaxel In Patients With Inoperable Stage IIIB Or IIIB or IV Non-Small Cell Lung Cancer|
- Response rate [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Tolerability [ Designated as safety issue: Yes ]
- Quality of life [ Designated as safety issue: No ]
|Study Start Date:||September 2003|
- Determine the response rate in patients with inoperable stage IIIB or IV non-small cell lung cancer treated with gemcitabine and docetaxel.
- 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.
|Bobigny, France, 93009|
|Centre Jean Bernard|
|Le Mans, France, 72000|
|Hopital Perpetuel Secours|
|Levallois-Perret, France, 92300|
|Centre de Radiotherapie et Oncologie Saint-Faron|
|Mareuil Les Meaux, France, 77100|
|Clinique de Docteur Terrioux|
|Meaux, France, 77100|
|American Hospital of Paris|
|Neuilly Sur Seine, France, F-92202|
|Paris, France, 75970|
|Polyclinique De Courlancy|
|Reims, France, F-51100|
|Clinique les Bleuets|
|Reims, France, 51100|
|Centre Rene Huguenin|
|Saint Cloud, France, 92211|
|Saint-Dizier, France, 52100|
|Hopital Paul Brousse|
|Villejuif, France, 94804|
|Investigator:||Philippe Terrioux, MD||Clinique de Docteur Terrioux|