Carboplatin, Paclitaxel, Selenomethionine, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Selenomethionine may slow the growth of tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with selenomethionine and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well selenomethionine works when given together with carboplatin, paclitaxel, and radiation therapy in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.
|Lung Cancer||Dietary Supplement: selenomethionine Drug: carboplatin Drug: paclitaxel Other: laboratory biomarker analysis Radiation: radiation therapy||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination With Radiation for Patients With Unresectable Stage III Non-Small Cell Lung Cancer: A Phase II, Multi-Center Trial|
- Incidence of Grade 3-4 Esophagitis [ Time Frame: During study treatment ]
- Incidence of Grade 3-4 Pneumonitis [ Time Frame: During Study Treatment ]
- Incidence of Grade 3-4 Myelosuppression [ Time Frame: During study treatment ]
- Response Rate [ Time Frame: 1 month post-treatment, then q 3 months x 4 ]
- Failure-free Survival [ Time Frame: Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter. ]
- Overall Survival [ Time Frame: Post-treatment follow-up every 3 months x4, then per institute standard of practice every 6 months for 2 years, then yearly therafter ]
- Correlation of Selenium Levels With Degree of Observed Adverse Events [ Time Frame: Pre-treatment and every week for 6 weeks prior to chemotherapy. ]Mann-Whitney-Wilcoxon test was used to test the correlation between selenium levels and serious adverse events. There was no significant correlation between selenium levels and serious adverse events (P=0.3149)
|Study Start Date:||October 2006|
|Study Completion Date:||September 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
Dietary Supplement: selenomethionine
Oral Twice dailyDrug: carboplatin
Weekly IVDrug: paclitaxel
Weekly IVOther: laboratory biomarker analysis
Correlative StudyRadiation: radiation therapy
Undergoing radiation Therapy
- Determine the safety and tolerability of selenomethionine in combination with chemotherapy and radiotherapy in patients with unresectable stage IIIA or IIIB non-small cell lung cancer.
- Determine if the incidence of excessive adverse events, in the form of esophagitis, pneumonitis, and myelosuppression, can be reduced with this regimen.
- Estimate response rate, failure-free survival, and overall survival of these patients.
- Correlate selenium levels with degree of observed adverse events.
OUTLINE: This is a multicenter study.
Patients receive oral selenomethionine twice daily for 1 week and then once daily for 6 weeks. Patients also receive paclitaxel IV over 1 hour once weekly and carboplatin IV over 30 minutes once weekly for 6 weeks and undergo radiotherapy 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and weekly during treatment and analyzed by absorption spectrophotometry for selenium measurement of drug concentration
After the completion of study treatment, patients are followed periodically.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00526890
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Jorge Gomez, MD||Roswell Park Cancer Institute|