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)
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
Scroll for more (66 remaining)Beebe Medical Center🇺🇸Lewes, Delaware, United States