NCT00182806

Irinotecan and Gemcitabine in Treating Patients With Recurrent or Progressive Stage III or Stage IV Non-Small Cell Lung Cancer

Phase II Study of Irinotecan Followed by Gemcitabine in NSCLC Following Failure of Platinum Based Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Irinotecan may also increase the effectiveness of gemcitabine. Giving irinotecan together with gemcitabine may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving irinotecan together with gemcitabine works in treating patients with recurrent or progressive stage III or stage IV non-small cell lung cancer.

Detailed description

OBJECTIVES: Primary * Determine the objective response rate (complete and partial response) in patients with recurrent or progressive stage IIIA-IV non-small cell lung cancer treated with irinotecan and gemcitabine. Secondary * Determine the median time to progression in patients treated with this regimen. OUTLINE: This a non-randomized, open-label, multicenter study. Patients receive irinotecan IV over 90 minutes on days 1 and 8 and gemcitabine IV over 30 minutes on days 2 and 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 1 month and then every 8 weeks thereafter. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 16 months.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine hydrochloride	IV over 30 minutes on days 2 and 9. Courses repeat every 21 days.
DRUG	irinotecan hydrochloride	IV over 90 minutes on days 1 and 8. Courses repeat every 21 days.

Timeline

• Start date: 2004-09-01
• Primary completion: 2007-09-01
• Completion: 2008-07-01
• First posted: 2005-09-16
• Last updated: 2012-03-06

Locations

1 site across 1 country: United States