NCT00004139

Gemcitabine Plus Docetaxel or Irinotecan in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Phase II Randomized Trial of Gemcitabine/Docetaxel and Gemcitabine/Irinotecan in Stage IIIB/IV Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (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 compare the effectiveness of gemcitabine plus either docetaxel or irinotecan in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Detailed description

OBJECTIVES: I. Compare the complete and overall response rate to gemcitabine and docetaxel versus gemcitabine and irinotecan in chemotherapy naive patients with stage IIIB or IV non-small cell lung cancer. II. Compare the overall and failure free survival, duration of response, and toxicity associated with these combination regimens in this patient population. OUTLINE: This is a randomized study. Patients are stratified according to disease stage (stage IIIB vs stage IV without CNS involvement vs stage IV with CNS involvement vs recurrent/progressive disease post surgery and/or radiotherapy). Patients are randomized to one of two treatment arms. Arm I: Patients receive gemcitabine IV over 30 minutes immediately followed by irinotecan IV over 90 minutes on days 1 and 8. Arm II: Patients receive gemcitabine IV over 30 minutes immediately followed by docetaxel IV over 60 minutes on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving partial or complete response or stable disease receive treatment for least 6 courses and for 2 additional courses beyond the maximum response, and then at the investigator's discretion. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter until disease progression or death. PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for this study within 12 months.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	docetaxel
DRUG	gemcitabine hydrochloride
DRUG	irinotecan hydrochloride

Timeline

• Start date: 1999-09-01
• Primary completion: 2004-07-01
• Completion: 2006-01-01
• First posted: 2004-05-25
• Last updated: 2016-07-20

Locations

8 sites across 1 country: United States