Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00075517|
Recruitment Status : Unknown
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 12, 2004
Last Update Posted : July 24, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: docetaxel Drug: gemcitabine hydrochloride||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study Of Gemcitabine And Docetaxel In Patients With Inoperable Stage IIIB Or IIIB or IV Non-Small Cell Lung Cancer|
|Study Start Date :||September 2003|
U.S. FDA Resources
- Response rate
- Progression-free survival
- Overall survival
- Quality of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00075517
|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|
|Clinique les Bleuets|
|Reims, France, 51100|
|Polyclinique De Courlancy|
|Reims, France, F-51100|
|Centre Rene Huguenin|
|Saint Cloud, France, 92211|
|Saint-Dizier, France, 52100|
|Hopital Paul Brousse|
|Villejuif, France, 94804|
|OverallOfficial:||Philippe Terrioux, MD||Clinique de Docteur Terrioux|