Chemotherapy and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00022308
- Lead Sponsor
- Fox Chase Cancer Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
South Jersey Regional Cancer Center
🇺🇸Millville, New Jersey, United States
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
🇺🇸Mount Holly, New Jersey, United States
Riverview Medical Center - Booker Cancer Center
🇺🇸Red Bank, New Jersey, United States
Community Medical Center
🇺🇸Toms River, New Jersey, United States
St. Francis Medical Center
🇺🇸Trenton, New Jersey, United States
Delaware County Memorial Hospital
🇺🇸Drexel Hill, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Reading Hospital and Medical Center
🇺🇸Reading, Pennsylvania, United States
South Jersey Regional Cancer Center🇺🇸Millville, New Jersey, United States