Cisplatin and Irinotecan Followed by Carboplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Radiation: radiation therapy
- Registration Number
- NCT00072527
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Induction and consolidation chemotherapy radiation therapy Induction chemotherapy (Cycles 1 and 2): Patients receive cisplatin 30 mg/m\^2 on days 1, 8, 22 and 29 and irinotecan 65 mg/m\^2 on days 1, 8, 22 and 29 for cycles 1 and 2. Consolidation chemotherapy (Cycles 3, 4 and 5 beginning on day 43, week 7): Patients receive carboplatin on days 43, 64 and 85, etoposide 100 mg/m\^2 IV on days 43-45, 64-66 and 85-87 and XRT 5 fractions/week starting on day 43 Induction and consolidation chemotherapy cisplatin Induction chemotherapy (Cycles 1 and 2): Patients receive cisplatin 30 mg/m\^2 on days 1, 8, 22 and 29 and irinotecan 65 mg/m\^2 on days 1, 8, 22 and 29 for cycles 1 and 2. Consolidation chemotherapy (Cycles 3, 4 and 5 beginning on day 43, week 7): Patients receive carboplatin on days 43, 64 and 85, etoposide 100 mg/m\^2 IV on days 43-45, 64-66 and 85-87 and XRT 5 fractions/week starting on day 43 Induction and consolidation chemotherapy etoposide Induction chemotherapy (Cycles 1 and 2): Patients receive cisplatin 30 mg/m\^2 on days 1, 8, 22 and 29 and irinotecan 65 mg/m\^2 on days 1, 8, 22 and 29 for cycles 1 and 2. Consolidation chemotherapy (Cycles 3, 4 and 5 beginning on day 43, week 7): Patients receive carboplatin on days 43, 64 and 85, etoposide 100 mg/m\^2 IV on days 43-45, 64-66 and 85-87 and XRT 5 fractions/week starting on day 43 Induction and consolidation chemotherapy carboplatin Induction chemotherapy (Cycles 1 and 2): Patients receive cisplatin 30 mg/m\^2 on days 1, 8, 22 and 29 and irinotecan 65 mg/m\^2 on days 1, 8, 22 and 29 for cycles 1 and 2. Consolidation chemotherapy (Cycles 3, 4 and 5 beginning on day 43, week 7): Patients receive carboplatin on days 43, 64 and 85, etoposide 100 mg/m\^2 IV on days 43-45, 64-66 and 85-87 and XRT 5 fractions/week starting on day 43 Induction and consolidation chemotherapy irinotecan hydrochloride Induction chemotherapy (Cycles 1 and 2): Patients receive cisplatin 30 mg/m\^2 on days 1, 8, 22 and 29 and irinotecan 65 mg/m\^2 on days 1, 8, 22 and 29 for cycles 1 and 2. Consolidation chemotherapy (Cycles 3, 4 and 5 beginning on day 43, week 7): Patients receive carboplatin on days 43, 64 and 85, etoposide 100 mg/m\^2 IV on days 43-45, 64-66 and 85-87 and XRT 5 fractions/week starting on day 43
- Primary Outcome Measures
Name Time Method Efficacy, in terms of survival, at 2 years after initiation of study treatment
- Secondary Outcome Measures
Name Time Method Overall response rate as measured by RECIST at completion of study treatment Overall survival Failure-free survival Response rate as measured by RECIST after completion of 2 courses of induction chemotherapy Toxicity as measured by NCI CTCAE v.30 after completion of 2 courses of chemotherapy Tolerability as measured by chemotherapy dose-delivered dose delays after completion of study treatment
Trial Locations
- Locations (76)
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
Hudner Oncology Center at Saint Anne's Hospital
🇺🇸Fall River, Massachusetts, United States
Saint Luke's Hospital
🇺🇸Chesterfield, Missouri, United States
Missouri Baptist Cancer Center
🇺🇸St. Louis, Missouri, United States
Comprehensive Cancer Center at Moore Regional Hospital
🇺🇸Pinehurst, North Carolina, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Beebe Medical Center
🇺🇸Lewes, Delaware, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
InterCommunity Cancer Center of Western Illinois
🇺🇸Galesburg, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
Oncology Hematology Associates of Central Illinois - Ottawa
🇺🇸Ottawa, 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
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
Valley Cancer Center
🇺🇸Spring Valley, Illinois, 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
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Fairview University Medical Center - University Campus
🇺🇸Minneapolis, Minnesota, United States
Veterans Affairs Medical Center - Buffalo
🇺🇸Buffalo, New York, United States
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸St Louis, Missouri, United States
Charles R. Wood Cancer Center at Glens Falls Hospital
🇺🇸Glens Falls, New York, United States
Zimmer Cancer Center at New Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, United States
Bon Secours St. Francis Health System
🇺🇸Greenville, South Carolina, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Eureka Hospital
🇺🇸Eureka, Illinois, United States
St. Francis Hospital
🇺🇸Wilmington, Delaware, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Kewanee Hospital
🇺🇸Kewanee, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Frisbie Memorial Hospital
🇺🇸Rochester, New Hampshire, United States
Union Hospital Cancer Center at Union Hospital
🇺🇸Elkton MD, Maryland, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
Methodist Medical Center of Illinois
🇺🇸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
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Lenoir Memorial Cancer Center
🇺🇸Kinston, North Carolina, United States
Comprehensive Cancer Center at Gaston Memorial
🇺🇸Gastonia, North Carolina, United States
Forsyth Regional Cancer Center at Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Methodist Cancer Center at Methodist Hospital - Omaha
🇺🇸Omaha, Nebraska, United States
Mercy Memorial Hospital System
🇺🇸Monroe, Michigan, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Saint Joseph Regional Medical Center - Plymouth Campus
🇺🇸Plymouth, Indiana, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
🇺🇸Columbus, Ohio, United States
Kingsbury Center for Cancer Care at Cheshire Medical Center
🇺🇸Keene, New Hampshire, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Faxton Regional Cancer Center
🇺🇸Utica, New York, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Pardee Memorial Hospital
🇺🇸Hendersonville, North Carolina, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Miriam Hospital at Lifespan
🇺🇸Providence, Rhode Island, United States
Greenville Hospital System Cancer Center
🇺🇸Greenville, South Carolina, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
Community General Hospital of Greater Syracuse
🇺🇸Syracuse, New York, United States
Galesburg Clinic
🇺🇸Galesburg, Illinois, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Cancer Institute of New Jersey at the Cooper University Hospital
🇺🇸Camden, New Jersey, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States