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
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
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of the combination therapies
Toxicity will be assessed for each patient after each cycle of therapy. The maximum tolerated dose (MTD) will be the dose level prior to the dose in which greater than one-third of patients experience a dose-limiting toxicity.
After each cycle of therapy
Gregory A. Masters, MD
Robert H. Lurie Cancer Center
United States: Federal Government
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