NCT00005972

Combination Chemotherapy in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer

Phase II Trial of Gemcitabine/Irinotecan as Second Line Therapy for Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• 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 recurrent or refractory small cell lung cancer.

Detailed description

OBJECTIVES: I. Determine the overall, complete, and partial response rates of patients with recurrent or refractory small cell lung cancer when treated with gemcitabine plus irinotecan. II. Determine the overall and failure free survival of these patients when treated with this regimen. III. Determine the duration of response of these patients after this treatment. IV. Evaluate the toxicity associated with the administration of this treatment in this patient population. OUTLINE: Patients are stratified according to prior response duration (progression 90 days or more after initial therapy vs progression less than 90 days after initial therapy or no response to initial therapy). Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, then every 6 months for 2 years, and then annually for 3 years. PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study over 12-18 months.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine hydrochloride
DRUG	irinotecan hydrochloride

Timeline

• Start date: 2000-05-01
• Primary completion: 2006-10-01
• Completion: 2008-02-01
• First posted: 2004-03-24
• Last updated: 2016-07-14

Locations

50 sites across 1 country: United States