Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00041314|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 9, 2009
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 carboplatin, gemcitabine, and exisulind in treating patients who have advanced non-small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: carboplatin Drug: exisulind Drug: gemcitabine hydrochloride||Phase 2|
- Determine the 18-month survival rate in patients with advanced non-small cell lung cancer treated with carboplatin, gemcitabine, and exisulind.
- Determine the feasibility and toxicity of this regimen in these patients.
- Determine the response rate, progression-free survival, and overall median survival of patients treated with this regimen.
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Chemotherapy repeats every 21 days for up to 6 courses. Patients also receive oral exisulind twice daily beginning on day 1 of course 1 and continuing until disease progression or unacceptable toxicity occurs.
Patients are followed every 3 months for 2 years and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Trial Of Carboplatin And Gemcitabine With Exisulind In Patients With Advanced Non-Small Cell Lung Cancer|
|Study Start Date :||August 2002|
|Actual Primary Completion Date :||July 2005|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00041314
Show 79 Study Locations
|Study Chair:||Gregory A. Masters, MD||NorthShore University HealthSystem Research Institute|