Cisplatin and Irinotecan Followed by Carboplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
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.
Drug: irinotecan hydrochloride
Radiation: radiation therapy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Induction Cisplatin/Irinotecan Followed By Combination Carboplatin, Etoposide And Chest Radiotherapy In Limited Stage Small Cell Lung Cancer: A Phase II Study|
- Efficacy, in terms of survival, at 2 years after initiation of study treatment
- 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
|Study Start Date:||November 2003|
|Study Completion Date:||January 2013|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
Experimental: Induction and consolidation chemotherapy
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
IVDrug: irinotecan hydrochloride
IVRadiation: radiation therapy
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00072527
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|Study Chair:||Michael J. Kelley, MD||Duke University|