S0119: Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00030433|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 15, 2013
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 combination chemotherapy in treating patients who have extensive-stage small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride||Phase 2|
- Determine the survival of patients with extensive stage small cell lung cancer treated with gemcitabine and irinotecan.
- Determine the response rates (confirmed and unconfirmed, complete and partial) of patients treated with this regimen.
- Determine the overall toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial Of Gemcitabine (NSC-613327) And Irinotecan (NSC-616348) In Patients With Untreated Extensive Stage Small Cell Lung Cancer (SCLC)|
|Study Start Date :||January 2002|
|Primary Completion Date :||February 2007|
|Study Completion Date :||November 2008|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030433
Show 102 Study Locations
|Study Chair:||Wallace L. Akerley, MD||Boston Medical Center|