Paclitaxel Plus Radiation Therapy in Treating Patients With Untreated Stage III 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.
|Lung Cancer||Drug: chemotherapy Drug: paclitaxel Radiation: radiation therapy||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||PH I Continuous Infusion Taxol in Combination With Thoracic Radiation Therapy in Untreated Locally Advanced Non-Small Cell Lung Cancer|
|Study Start Date:||January 1997|
|Study Completion Date:||January 2000|
|Primary Completion Date:||January 2000 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002519
|United States, Pennsylvania|
|University of Pennsylvania Cancer Center|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Tennessee|
|Sarah Cannon-Minnie Pearl Cancer Center|
|Nashville, Tennessee, United States, 37203|
|Vanderbilt Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Study Chair:||David P. Carbone, MD, PhD||Vanderbilt-Ingram Cancer Center|