NCT00003881

Trastuzumab Plus Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer

Phase II Pilot Trial of Carboplatin, Paclitaxel, and Herceptin in HER2/Neu (+) Advanced NSCLC

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Eastern Cooperative Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of the monoclonal antibody trastuzumab plus carboplatin and paclitaxel in treating patients who have advanced non-small cell lung cancer.

Detailed description

OBJECTIVES: I. Assess the toxicity of monoclonal antibody HER2 with carboplatin and paclitaxel in patients with HER2 positive non-small cell lung cancer. II. Determine median time to progression and one year freedom from progression in this patient population. III. Evaluate one year survival rate and overall objective response rate in this patient population. OUTLINE: Patients receive paclitaxel IV over 3 hours immediately followed by carboplatin IV over 30 minutes immediately followed by monoclonal antibody HER2 IV over 30-90 minutes on day 1. Patients also receive monoclonal antibody HER2 on days 8 and 15. Treatment is repeated every 3 weeks for 6 courses. After 6 courses of treatment, patients may receive monoclonal antibody HER2 weekly for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years and once a year thereafter until disease progression or death. PROJECTED ACCRUAL: A total of 22-44 patients will be accrued for this study.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	trastuzumab
DRUG	carboplatin
DRUG	paclitaxel

Timeline

• Start date: 1999-05-01
• Completion: 2004-07-01
• First posted: 2004-07-19
• Last updated: 2013-06-21

Locations

71 sites across 3 countries: United States, Puerto Rico, South Africa