NCT00030433

S0119: Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Phase II Trial Of Gemcitabine (NSC-613327) And Irinotecan (NSC-616348) In Patients With Untreated Extensive Stage Small Cell Lung Cancer (SCLC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine hydrochloride
DRUG	irinotecan hydrochloride

Timeline

• Start date: 2002-01-01
• Primary completion: 2007-02-01
• Completion: 2008-11-01
• First posted: 2003-01-27
• Last updated: 2013-02-15

Locations

102 sites across 1 country: United States