Irinotecan and Carboplatin in Treating Patients With Newly Diagnosed Extensive-Stage Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving irinotecan together with carboplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works in treating patients with newly diagnosed extensive-stage small cell lung cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Weekly Irinotecan and Carboplatin in Extensive-Stage Small-Cell Lung Cancer|
- Response [ Designated as safety issue: No ]
- Survival [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
|Study Start Date:||June 2003|
|Study Completion Date:||November 2008|
|Primary Completion Date:||February 2007 (Final data collection date for primary outcome measure)|
- Determine the response rate in patients with newly diagnosed, previously untreated extensive stage small cell lung cancer treated with irinotecan and carboplatin.
- Determine the progression-free and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive irinotecan IV and carboplatin IV on days 1 and 8. Treatment repeats every 21 days for 6 courses.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104793
|National Hospital Organization - Dohoku National Hospital|
|Asahikawa, Hokkaido, Japan, 070-0901|
|Fujisawa City Hospital|
|Fujisawa, Kanagawa, Japan, 251-8550|
|Kurashiki Central Hospital|
|Kurashiki-shi, Okayama, Japan, 710-8602|
|Osaka General Medical Center|
|Osaka-shi, Osaka, Japan, 558-0056|
|National Hospital Organization - Osaka National Hospital|
|Sakai, Osaka, Japan, 591-8555|
|Takatsuki Red Cross Hospital|
|Takatsuki, Osaka, Japan, 569-1096|
|Yao Tokusyu-kai General Hospital|
|Yao, Osaka, Japan, 561-0072|
|Gunma Cancer Center|
|Gunma, Japan, 373-8550|
|National Hospital Organization - Medical Center of Kure|
|Hiroshima, Japan, 737-0023|
|Osaka Kosei Nenkin Hospital|
|Osaka, Japan, 553-0003|
|Tokyo Medical and Dental University|
|Tokyo, Japan, 113-8519|
|Study Chair:||Tadashi Mio, MD||Kyoto University|