Phase I Study of Irinotecan and Cisplatin in Combination With Twice Daily Thoracic Radiotherapy (45 Gy) or Once Daily Thoracic Radiotherapy (70 Gy) for Patients With Limited Stage Small Cell Lung Cancer
- Determine the maximum tolerated dose of irinotecan administered with cisplatin and
thoracic radiotherapy (given at two different schedules) in patients with limited stage
small cell lung cancer.
- Determine the qualitative and quantitative toxicity and non-dose-limiting toxicity of
these regimens in these patients.
- Determine the reversibility of all toxic effects associated with these regimens in
OUTLINE: This is a non-randomized, dose-escalation study of irinotecan. Patients are
assigned to 1 of 2 radiotherapy (RT) treatment groups.
- Group I: Patients undergo thoracic RT twice daily, 5 days a week, for 3 weeks.
- Group II: Patients undergo thoracic RT once daily, 5 days a week, for 7 weeks.
- Concurrent chemotherapy: Patients receive irinotecan IV over 60-90 minutes on days 1
and 8 and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 1
course for group I and 2 courses for group II.
- Post RT chemotherapy: Patients receive irinotecan and cisplatin as above for 3 courses
for group I and 2 courses, beginning after RT is complete, for group II.
Sequential cohorts of 6 patients per group 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 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 1 year and then 6 months for 4 years.
PROJECTED ACCRUAL: A total of 12-36 patients (6-18 per group) will be accrued for this study
within 18 months.
Primary Purpose: Treatment
Maximum tolerated dose of irinotecan in combination with cisplatin and thoracic radiotherapy (45 Gy BID or 70 Gy daily) by toxicity assessment (Common Toxicity Criteria version 3.0) during acute and late toxicity
Corey J. Langer, MD
Fox Chase Cancer Center
United States: Federal Government
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|CCOP - Mount Sinai Medical Center||Miami Beach, Florida 33140|
|Penn State Cancer Institute at Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033-0850|
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center||La Crosse, Wisconsin 54601|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|Providence Saint Joseph Medical Center - Burbank||Burbank, California 91505|
|CCOP - Bay Area Tumor Institute||Oakland, California 94609-3305|
|Albert Einstein Cancer Center||Philadelphia, Pennsylvania 19141|
|CCOP - Greenville||Greenville, South Carolina 29615|
|Dixie Regional Medical Center||Saint George, Utah 84770|
|LDS Hospital||Salt Lake City, Utah 84143|
|Ellis Fischel Cancer Center at University of Missouri - Columbia||Columbia, Missouri 65203|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia||Philadelphia, Pennsylvania 19107|
|Utah Valley Regional Medical Center - Provo||Provo, Utah 84604|
|Monmouth Medical Center||Long Branch, New Jersey 07740-6395|
|McDowell Cancer Center at Akron General Medical Center||Akron, Ohio 44307|
|M.D. Anderson Cancer Center at University of Texas||Houston, Texas 77030|
|Comprehensive Cancer Center at University of Alabama at Birmingham||Birmingham, Alabama 35294|
|University of Florida Shands Cancer Center||Gainesville, Florida 32610-0232|
|Baptist-South Miami Regional Cancer Program||Miami, Florida 33176|
|SUNY Upstate Medical University Hospital||Syracuse, New York 13210|
|Greenville Hospital System Cancer Center||Greenville, South Carolina 29605|
|William Beaumont Hospital - Royal Oak Campus||Royal Oak, Michigan 48073|
|Fox Chase Virtua Health Cancer Program - Marlton||Marlton, New Jersey 08053|
|Wayne Memorial Hospital, Incorporated||Goldsboro, North Carolina 27534|
|Cottonwood Hospital Medical Center||Murray, Utah 84107|
|McKay-Dee Hospital Center||Ogden, Utah 84403|
|Utah Cancer Specialists at UCS Cancer Center||Salt Lake City, Utah 84106|
|Memorial Cancer Institute at Memorial Regional Hospital||Hollywood, Florida 33021|
|Summit Medical Center||Oakland, California 94609|
|Saint Rose Hospital||Hayward, California 94545|
|Highland General Hospital at St. George's University School of Medicine||Oakland, California 94602|
|J.C. Robinson, M.D. Regional Cancer Center||San Pablo, California 94806|
|Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital||Fort Lauderdale, Florida 33308|
|Ella Milbank Foshay Cancer Center at Jupiter Medical Center||Jupiter, Florida 33458|
|Wayne Radiation Oncology||Goldsboro, North Carolina 27534|
|Wilson Medical Center||Wilson, North Carolina 27893-3428|
|Delaware County Regional Cancer Center at Delaware County Memorial Hospital||Drexel Hill, Pennsylvania 19026|
|Bon Secours St. Francis Health System||Greenville, South Carolina 29601|
|Valley Memorial Hospital||Livermore, California 94550|
|Wendt Regional Cancer Center at Finley Hospital||Dubuque, Iowa 52001|
|AtlantiCare Regional Medical Center||Pomona, New Jersey 08240|
|Tucker Center for Cancer Care at Orange Regional Medical Center||Middletown, New York 10940-4199|
|Mercy Cancer Institute at Mercy Hospital||Pittsburgh, Pennsylvania 15219|
|Sarah Cannon Cancer Center at Parkridge Medical Center||Chattanooga, Tennessee 37404-3285|