Cisplatin and Gemcitabine Plus Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Registration Number
- NCT00016367
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.
PURPOSE: Phase II trial to study effectiveness of combining cisplatin, gemcitabine, and trastuzumab in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
- Detailed Description
OBJECTIVES: I. Determine the therapeutic efficacy and toxicity of cisplatin, gemcitabine, and trastuzumab (Herceptin) in patients with untreated p185-HER2 overexpressing stage IIIB or IV non-small cell lung cancer. II. Determine the pharmacokinetic interactions among these drugs in these patients. III. Assess the pharmacodynamics of these drugs in these patients.
OUTLINE: This is a multicenter study. Regimen A: Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 2 hours on day 1 and trastuzumab (Herceptin) IV over 90 minutes on day 2. Patients receive trastuzumab IV over 90 minutes followed by gemcitabine IV over 30 minutes on day 8 and trastuzumab IV over 90 minutes on day 15. Patients proceed to regimen B on day 22 of regimen A. Regimen B: Patients receive trastuzumab IV over 30-90 minutes, gemcitabine IV over 30 minutes, and cisplatin IV over 2 hours on day 1. Patients receive trastuzumab IV over 30-90 minutes followed by gemcitabine IV over 30 minutes on day 8 and trastuzumab IV over 30-90 minutes on day 15. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Maintenance: After completion of 6 courses, patients with stable disease or partial response receive trastuzumab IV over 30-90 minutes weekly until tumor progression.
PROJECTED ACCRUAL: A total of 20-48 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Regimen B Trastuzumab Starting Day 22 of regimen A, Trastuzumab IV, Gemcitabine IV, and Cisplatin IV Day 1. Trastuzumab IV followed by Gemcitabine IV Day 8 and Trastuzumab IV Day 15. Repeats every 21 days for up to 5 courses. Regimen A Trastuzumab Gemcitabine IV followed by Cisplatin IV Day 1 and Trastuzumab (Herceptin) IV Day 2; Trastuzumab IV followed by Gemcitabine IV Day 8 and Trastuzumab IV Day 15. Regimen A Gemcitabine Hydrochloride Gemcitabine IV followed by Cisplatin IV Day 1 and Trastuzumab (Herceptin) IV Day 2; Trastuzumab IV followed by Gemcitabine IV Day 8 and Trastuzumab IV Day 15. Regimen B Gemcitabine Hydrochloride Starting Day 22 of regimen A, Trastuzumab IV, Gemcitabine IV, and Cisplatin IV Day 1. Trastuzumab IV followed by Gemcitabine IV Day 8 and Trastuzumab IV Day 15. Repeats every 21 days for up to 5 courses. Regimen A Cisplatin Gemcitabine IV followed by Cisplatin IV Day 1 and Trastuzumab (Herceptin) IV Day 2; Trastuzumab IV followed by Gemcitabine IV Day 8 and Trastuzumab IV Day 15. Regimen B Cisplatin Starting Day 22 of regimen A, Trastuzumab IV, Gemcitabine IV, and Cisplatin IV Day 1. Trastuzumab IV followed by Gemcitabine IV Day 8 and Trastuzumab IV Day 15. Repeats every 21 days for up to 5 courses.
- Primary Outcome Measures
Name Time Method Efficacy of Cisplatin, Gemcitabine, + Trastuzumab in Untreated p185-HER2 Overexpressing Stage IIIB or IV Non-small Cell Lung Cancer 21 days cycles for 6 courses
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States