Spots Global Cancer Trial Database for Cisplatin and Irinotecan Followed by Carboplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
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Trial Identification
Brief Title: Cisplatin and Irinotecan Followed by Carboplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Official Title: Induction Cisplatin/Irinotecan Followed By Combination Carboplatin, Etoposide And Chest Radiotherapy In Limited Stage Small Cell Lung Cancer: A Phase II Study
Study ID: NCT00072527
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as cisplatin, irinotecan, carboplatin, and etoposide, 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 II trial to study the effectiveness of cisplatin and irinotecan followed by carboplatin, etoposide, and radiation therapy in treating patients who have limited-stage small cell lung cancer.
Detailed Description: OBJECTIVES: Primary * Determine the efficacy of cisplatin and irinotecan followed by carboplatin, etoposide, and radiotherapy, in terms of 2-year survival, in patients with limited stage small cell lung cancer. Secondary * Determine the overall response rate, overall survival, and failure-free survival of patients treated with this regimen. * Determine the response rate in patients treated with induction therapy comprising irinotecan and cisplatin. * Determine the toxicity and tolerability of this regimen in these patients. OUTLINE: This is a multicenter study. * Induction therapy: Patients receive cisplatin IV over 60 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. * Consolidation therapy: Immediately after the completion of induction therapy, patients receive carboplatin IV over 60 minutes on day 1 and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. * Radiotherapy: Beginning on day 1 of consolidation therapy, patients undergo chest radiotherapy daily 5 days a week for 6-7 weeks. After the completion of consolidation therapy, patients who achieve a complete remission or very good partial remission may undergo prophylactic radiotherapy to the brain. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years. PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 15-24 months.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Beebe Medical Center, Lewes, Delaware, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
St. Francis Hospital, Wilmington, Delaware, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, United States
St. Joseph Medical Center, Bloomington, Illinois, United States
Graham Hospital, Canton, Illinois, United States
Memorial Hospital, Carthage, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Eureka Hospital, Eureka, Illinois, United States
Galesburg Clinic, Galesburg, Illinois, United States
Galesburg Cottage Hospital, Galesburg, Illinois, United States
InterCommunity Cancer Center of Western Illinois, Galesburg, Illinois, United States
Mason District Hospital, Havana, Illinois, United States
Hopedale Medical Complex, Hopedale, Illinois, United States
Kewanee Hospital, Kewanee, Illinois, United States
McDonough District Hospital, Macomb, Illinois, United States
BroMenn Regional Medical Center, Normal, Illinois, United States
Community Cancer Center, Normal, Illinois, United States
Community Hospital of Ottawa, Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois - Ottawa, Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital, Pekin, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
Proctor Hospital, Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C., Peoria, Illinois, United States
OSF St. Francis Medical Center, Peoria, Illinois, United States
Illinois Valley Community Hospital, Peru, Illinois, United States
Perry Memorial Hospital, Princeton, Illinois, United States
St. Margaret's Hospital, Spring Valley, Illinois, United States
Valley Cancer Center, Spring Valley, Illinois, United States
Elkhart General Hospital, Elkhart, Indiana, United States
Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana, United States
Saint Joseph Regional Medical Center - Plymouth Campus, Plymouth, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, United States
Union Hospital Cancer Center at Union Hospital, Elkton MD, Maryland, United States
Hudner Oncology Center at Saint Anne's Hospital, Fall River, Massachusetts, United States
Mercy Memorial Hospital System, Monroe, Michigan, United States
Fairview University Medical Center - University Campus, Minneapolis, Minnesota, United States
Saint Luke's Hospital, Chesterfield, Missouri, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, United States
CCOP - Kansas City, Kansas City, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital, St Louis, Missouri, United States
Missouri Baptist Cancer Center, St. Louis, Missouri, United States
Methodist Cancer Center at Methodist Hospital - Omaha, Omaha, Nebraska, United States
Kingsbury Center for Cancer Care at Cheshire Medical Center, Keene, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Frisbie Memorial Hospital, Rochester, New Hampshire, United States
Cancer Institute of New Jersey at the Cooper University Hospital, Camden, New Jersey, United States
Veterans Affairs Medical Center - Buffalo, Buffalo, New York, United States
Charles R. Wood Cancer Center at Glens Falls Hospital, Glens Falls, New York, United States
North Shore University Hospital, Manhasset, New York, United States
Long Island Jewish Medical Center, New Hyde Park, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York, United States
SUNY Upstate Medical University Hospital, Syracuse, New York, United States
Community General Hospital of Greater Syracuse, Syracuse, New York, United States
Faxton Regional Cancer Center, Utica, New York, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Comprehensive Cancer Center at Gaston Memorial, Gastonia, North Carolina, United States
Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States
Pardee Memorial Hospital, Hendersonville, North Carolina, United States
Lenoir Memorial Cancer Center, Kinston, North Carolina, United States
Comprehensive Cancer Center at Moore Regional Hospital, Pinehurst, North Carolina, United States
Zimmer Cancer Center at New Hanover Regional Medical Center, Wilmington, North Carolina, United States
Forsyth Regional Cancer Center at Forsyth Medical Center, Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus, Ohio, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Miriam Hospital at Lifespan, Providence, Rhode Island, United States
Bon Secours St. Francis Health System, Greenville, South Carolina, United States
Greenville Hospital System Cancer Center, Greenville, South Carolina, United States
CCOP - Greenville, Greenville, South Carolina, United States
Danville Regional Medical Center, Danville, Virginia, United States
Contact Details
Name: Michael J. Kelley, MD
Affiliation: Duke University
Role: STUDY_CHAIR
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