Carboplatin, Irinotecan, and Radiation Therapy Followed By Docetaxel in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as carboplatin, irinotecan, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving carboplatin and irinotecan together with radiation therapy followed by docetaxel works in treating patients with newly diagnosed stage III non-small cell lung cancer.
Drug: irinotecan hydrochloride
Radiation: radiation therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Carboplatin and Irinotecan Concomitantly With Radiation Therapy Followed by Consolidation Chemotherapy With Docetaxel for Locally Advanced Non-Small Cell Lung Cancer (GIA 12177).|
- Response (complete response, partial response, overall response) as measured by RECIST criteria prior to course 1 and within 1 month after completion of course 3 of consolidation chemotherapy [ Time Frame: 5.25 years ] [ Designated as safety issue: No ]
- Toxicity/safety profile as measured by NCI CTCAE v 3.0 [ Time Frame: 5.25 years ] [ Designated as safety issue: Yes ]
- Median survival [ Time Frame: 5.25 years ] [ Designated as safety issue: No ]
- 1-year survival [ Time Frame: 5.25 years ] [ Designated as safety issue: No ]
- 2-year survival [ Time Frame: 5.25 years ] [ Designated as safety issue: No ]
- Time to disease progression [ Time Frame: 5.25 years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2004|
|Study Completion Date:||January 2008|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
- Determine the objective response rate in patients with newly diagnosed stage IIIA or IIIB non-small cell lung cancer treated with concurrent carboplatin, irinotecan hydrochloride, and radiotherapy followed by consolidation docetaxel.
- Evaluate the safety, toxicity, and complications of this regimen in these patients.
- Evaluate the median survival, 1-year and 2-year survival, and time to tumor progression in these patients.
- Chemoradiotherapy: Patients receive carboplatin IV over 30 minutes followed by irinotecan hydrochloride IV over 90 minutes on day 1. Patients also undergo radiotherapy once daily on days 1-5. Treatment repeats weekly for up to 7 courses in the absence of disease progression or unacceptable toxicity.
- Consolidation chemotherapy: Beginning 3-4 weeks after completion of chemoradiotherapy, patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 4 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00449020
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center|
|Miami, Florida, United States, 33136|
|Study Chair:||Luis E. Raez, MD, FACP||University of Miami Sylvester Comprehensive Cancer Center|