RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of chemotherapy with paclitaxel in combination with radiation therapy to the chest in patients with previously untreated stage III non-small cell lung cancer that cannot be surgically removed.
OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of paclitaxel when combined with standard thoracic radiotherapy in patients with locally advanced non-small cell lung cancer. II. Determine the plasma levels of paclitaxel in these patients. III. Determine the effect of this regimen on the tumor cell cycle distribution in these patients. OUTLINE: This is a dose-escalation study of paclitaxel. Patients undergo standard thoracic radiotherapy 5 days a week for 7 weeks. Patients receive paclitaxel IV continuously beginning 48 hours before initiating radiotherapy and continuing until the last day of radiotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-5 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose-limiting toxicity. Patients are followed monthly for 2 years. PROJECTED ACCRUAL: A total of 3-5 patients per dose level will be accrued for this study within 2 years.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
6
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Sarah Cannon-Minnie Pearl Cancer Center
Nashville, Tennessee, United States
Vanderbilt Cancer Center
Nashville, Tennessee, United States
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