Cisplatin and Irinotecan Followed by Carboplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00072527|
Recruitment Status : Completed
First Posted : November 5, 2003
Last Update Posted : July 6, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: carboplatin Drug: cisplatin Drug: etoposide Drug: irinotecan hydrochloride Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||November 2003|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||January 2013|
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
Drug: irinotecan hydrochloride
Radiation: radiation therapy
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072527
|Study Chair:||Michael J. Kelley, MD||Duke University|