Chemotherapy Combined With Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring limited stage small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed small cell lung cancer by one of two methods: Fine needle aspiration biopsy Two positive sputa Must have limited disease as defined by all of the following: Stage I-IIIB Confined to 1 hemithorax No T4 tumor based on malignant pleural or pericardial effusion Patients with pleural effusion too small to tap under CT guidance and not evident on chest x-ray are allowed No N3 disease based on contralateral hilar or contralateral supraclavicular involvement Measurable or evaluable disease Tumor must be able to be encompassed by specified radiotherapy fields without unacceptable risk of serious pulmonary compromise No complete tumor resection No pericardial effusion (regardless of cytology) PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 120,000/mm^3 Hepatic Bilirubin no greater than 1.5 mg/dL No known Gilbert's disease Renal Creatinine no greater than 1.5 mg/dL Cardiovascular No myocardial infarction within the past 6 months No symptomatic heart disease Pulmonary Forced expiratory volume (FEV)_1 at least 1.0 L/sec No uncontrolled bronchospasms No uncompensated chronic obstructive pulmonary disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No pre-existing peripheral neuropathy grade 2 or greater No other malignancy within the past 2 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the bladder or cervix No other concurrent serious medical illness PRIOR CONCURRENT THERAPY: Biologic therapy No prior biologic therapy Chemotherapy No prior chemotherapy Endocrine therapy Not specified Radiotherapy No prior radiotherapy No concurrent intensity-modulated radiotherapy Surgery See Disease Characteristics Other At least 7 days since prior enzyme-inducing anti-convulsant drugs (EIACDs) (e.g., phenytoin, carbamazepine, or phenobarbital) if used on a regular basis for more than 2 weeks Less than 2 weeks of regular use of EIACDs does not require a 7-day wash-out period At least 14 days since prior Hypericum perforatum (St. John's wort) No concurrent EIACDs No concurrent amifostine during chemoradiotherapy Concurrent gabapentin or other non-EIACDs allowed
Sites / Locations
- Comprehensive Cancer Center at University of Alabama at Birmingham
- Providence Saint Joseph Medical Center - Burbank
- Saint Rose Hospital
- Valley Memorial Hospital
- Highland General Hospital at St. George's University School of Medicine
- CCOP - Bay Area Tumor Institute
- Summit Medical Center
- J.C. Robinson, M.D. Regional Cancer Center
- CCOP - Christiana Care Health Services
- Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
- University of Florida Shands Cancer Center
- Memorial Cancer Institute at Memorial Regional Hospital
- Ella Milbank Foshay Cancer Center at Jupiter Medical Center
- CCOP - Mount Sinai Medical Center
- Baptist-South Miami Regional Cancer Program
- University of Chicago Cancer Research Center
- Wendt Regional Cancer Center at Finley Hospital
- Massachusetts General Hospital Cancer Center
- William Beaumont Hospital - Royal Oak Campus
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- Monmouth Medical Center
- Fox Chase Virtua Health Cancer Program - Marlton
- AtlantiCare Regional Medical Center
- Tucker Center for Cancer Care at Orange Regional Medical Center
- SUNY Upstate Medical University Hospital
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Duke Comprehensive Cancer Center
- Wayne Memorial Hospital, Incorporated
- Wayne Radiation Oncology
- Wilson Medical Center
- McDowell Cancer Center at Akron General Medical Center
- Delaware County Regional Cancer Center at Delaware County Memorial Hospital
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Albert Einstein Cancer Center
- Mercy Cancer Institute at Mercy Hospital
- Bon Secours St. Francis Health System
- Greenville Hospital System Cancer Center
- CCOP - Greenville
- Sarah Cannon Cancer Center at Parkridge Medical Center
- Vanderbilt-Ingram Cancer Center
- M.D. Anderson Cancer Center at University of Texas
- Cottonwood Hospital Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center - Provo
- Utah Cancer Specialists at UCS Cancer Center
- LDS Hospital
- Dixie Regional Medical Center
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Sequence A: Level 1
Sequence B: Level 1
Sequence A: Level 2
Sequence B: Level 2
Sequence A: Level 3
Sequence B: Level 3
Irinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID
Irinotecan 40 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily
Irinotecan 50 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID
Irinotecan 50 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily
Irinotecan 60 mg/m2, cisplatin 60 mg/m2, concurrent radiation therapy (RT) at 1.5 Gy BID
Irinotecan 60 mg/m2, cisplatin 60 mg/m2, concurrent RT at 2 Gy once daily