Chemotherapy Combined With Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Registration Number
- NCT00059761
- Lead Sponsor
- Radiation Therapy Oncology Group
- 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 effect on the body when combining irinotecan and cisplatin with radiation therapy in treating patients who have limited-stage small cell lung cancer that could not be completely removed during surgery.
- Detailed Description
OBJECTIVES:
* 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 these patients.
OUTLINE: This is a non-randomized, dose-escalation study of irinotecan. Patients are assigned to 1 of 2 radiotherapy (RT) treatment groups.
* Radiotherapy:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sequence B: Level 2 radiation therapy Irinotecan 50 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily Sequence A: Level 1 radiation therapy Irinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID Sequence B: Level 1 radiation therapy Irinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily Sequence A: Level 2 radiation therapy Irinotecan 50 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID Sequence A: Level 3 radiation therapy Irinotecan 60 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID Sequence B: Level 3 cisplatin Irinotecan 60 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily Sequence B: Level 3 irinotecan hydrochloride Irinotecan 60 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily Sequence B: Level 3 radiation therapy Irinotecan 60 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily Sequence A: Level 1 irinotecan hydrochloride Irinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID Sequence A: Level 1 cisplatin Irinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID Sequence B: Level 1 cisplatin Irinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily Sequence B: Level 1 irinotecan hydrochloride Irinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily Sequence A: Level 2 irinotecan hydrochloride Irinotecan 50 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID Sequence A: Level 2 cisplatin Irinotecan 50 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID Sequence B: Level 2 cisplatin Irinotecan 50 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily Sequence A: Level 3 cisplatin Irinotecan 60 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID Sequence B: Level 2 irinotecan hydrochloride Irinotecan 50 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily Sequence A: Level 3 irinotecan hydrochloride Irinotecan 60 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID
- Primary Outcome Measures
Name Time Method 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 From the start of treatment until 90 days
- Secondary Outcome Measures
Name Time Method Rate of non-dose limiting toxicity From start of treatment to the end of follow-up
Trial Locations
- Locations (49)
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
Albert Einstein Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Florida Shands Cancer Center
🇺🇸Gainesville, Florida, United States
Providence Saint Joseph Medical Center - Burbank
🇺🇸Burbank, California, United States
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Valley Memorial Hospital
🇺🇸Livermore, California, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Memorial Cancer Institute at Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Summit Medical Center
🇺🇸Oakland, California, United States
Greenville Hospital System Cancer Center
🇺🇸Greenville, South Carolina, United States
Monmouth Medical Center
🇺🇸Long Branch, New Jersey, United States
Fox Chase Virtua Health Cancer Program - Marlton
🇺🇸Mount Holly, New Jersey, United States
Tucker Center for Cancer Care at Orange Regional Medical Center
🇺🇸Middletown, New York, United States
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
🇺🇸Drexel Hill, Pennsylvania, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
William Beaumont Hospital - Royal Oak Campus
🇺🇸Royal Oak, Michigan, United States
Highland General Hospital at St. George's University School of Medicine
🇺🇸Oakland, California, United States
AtlantiCare Regional Medical Center
🇺🇸Pomona, New Jersey, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Saint Rose Hospital
🇺🇸Hayward, California, United States
J.C. Robinson, M.D. Regional Cancer Center
🇺🇸San Pablo, California, United States
Wendt Regional Cancer Center at Finley Hospital
🇺🇸Dubuque, Iowa, United States
McDowell Cancer Center at Akron General Medical Center
🇺🇸Akron, Ohio, United States
McKay-Dee Hospital Center
🇺🇸Ogden, Utah, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Wilson Medical Center
🇺🇸Wilson, North Carolina, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Bon Secours St. Francis Health System
🇺🇸Greenville, South Carolina, United States
Sarah Cannon Cancer Center at Parkridge Medical Center
🇺🇸Chattanooga, Tennessee, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Cottonwood Hospital Medical Center
🇺🇸Murray, Utah, United States
Dixie Regional Medical Center
🇺🇸St. George, Utah, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
🇺🇸La Crosse, Wisconsin, United States
Mercy Cancer Institute at Mercy Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Baptist-South Miami Regional Cancer Program
🇺🇸Miami, Florida, United States
M.D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Utah Cancer Specialists at UCS Cancer Center
🇺🇸Salt Lake City, Utah, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
Comprehensive Cancer Center at University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Wayne Radiation Oncology
🇺🇸Goldsboro, North Carolina, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
🇺🇸Jupiter, Florida, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States