Lung Cancer Clinical Trial
Official title:
PH I Continuous Infusion Taxol in Combination With Thoracic Radiation Therapy in Untreated Locally Advanced Non-Small Cell Lung Cancer
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.
;
Primary Purpose: Treatment
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