Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title: A Phase I-II Study of Induction Chemotherapy With Carboplatin and Gemcitabine, Followed by Chemoradiotherapy With Paclitaxel and Vinorelbine for Patients With Locally Advanced Non-Small Cell Lung Cancer

Status Terminated

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have stage III non-small cell lung cancer.

Clinical Trial Description

OBJECTIVES: I. Determine the feasibility of the concurrent chemoradiotherapy regimen of paclitaxel and vinorelbine with standard chest radiotherapy in patients with locally advanced non-small cell lung cancer. II. Determine the maximum tolerated dose and dose limiting toxicities of this regimen in this patient population. III. Determine the radiologic response rate of induction chemotherapy with carboplatin and gemcitabine in this patient population. IV. Evaluate the pathologic response rate in patients undergoing resection. V. Evaluate the time to progression, overall survival, and quality of life in this patient population.

OUTLINE: This is a dose escalation study of vinorelbine. Patients receive induction chemotherapy consisting of carboplatin IV over 30 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for 2 courses. At 2 weeks following completion of induction chemotherapy, patients receive vinorelbine IV over 10 minutes followed by paclitaxel IV over 60 minutes weekly and radiotherapy daily for 5 consecutive days a week on weeks 1-6. Following initial induction chemotherapy, patients with stable or regressive disease may receive an additional 2-4 courses of carboplatin and gemcitabine at investigator's discretion. At approximately 2-6 weeks following completion of chemoradiotherapy, patients with resectable/operable disease undergo surgical resection. Cohorts of 3-6 patients receive escalating doses of vinorelbine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose limiting toxicity. Quality of life is assessed in all patients. Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 38-47 patients will be accrued for this study within 12-18 months. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

• NCT number: NCT00004093
• Study type: Interventional
• Source: Northwestern University
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: August 1999
• Completion date: March 2002