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|
|Actual Primary Completion Date :||September 2006|
|Actual Study Completion Date :||September 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|