Chemotherapy and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00022308|
Recruitment Status : Completed
First Posted : February 27, 2004
Last Update Posted : September 2, 2013
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 with radiation therapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have locally advanced non-small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: cisplatin Drug: irinotecan hydrochloride Radiation: radiation therapy||Phase 1|
OBJECTIVES: I. Determine the maximum tolerated dose of irinotecan when administered with cisplatin and radiotherapy in patients with locally advanced non-small cell lung carcinoma. II. Determine the toxic effects, especially acute and long-term esophagitis and pneumonitis, of this regimen in these patients. III. Determine the response rate, duration to progression, and sites of relapse in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of irinotecan. Patients receive irinotecan IV over 90 minutes and cisplatin over 1 hour on day 1. Patients also undergo radiotherapy once daily on days 1-5. Treatment repeats every 7 days for 7 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan 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 6 patients experience dose-limiting toxicity. Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 3-27 patients will be accrued for this study within 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I Trial of Radical Thoracic Radiation, Weekly CPT-11 (Irinotecan) and Cisplatin in Locally Advanced Non-Small Cell Lung Carcinoma|
|Study Start Date :||January 1999|
|Primary Completion Date :||September 2006|
|Study Completion Date :||September 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00022308
|United States, New Jersey|
|South Jersey Regional Cancer Center|
|Millville, New Jersey, United States, 08332|
|Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County|
|Mount Holly, New Jersey, United States, 08060|
|Riverview Medical Center - Booker Cancer Center|
|Red Bank, New Jersey, United States, 07701|
|Community Medical Center|
|Toms River, New Jersey, United States, 08755|
|St. Francis Medical Center|
|Trenton, New Jersey, United States, 08629|
|United States, Pennsylvania|
|Delaware County Memorial Hospital|
|Drexel Hill, Pennsylvania, United States, 19026|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|Reading Hospital and Medical Center|
|Reading, Pennsylvania, United States, 19612-6052|
|Study Chair:||Corey J. Langer, MD||Fox Chase Cancer Center|