S0119: Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
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|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|
|Actual Primary Completion Date :||February 2007|
|Actual Study Completion Date :||November 2008|
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): NCT00030433
Show 102 Study Locations
|Study Chair:||Wallace L. Akerley, MD||Boston Medical Center|