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
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of esophagitis, pneumonitis, and myelosuppression
No
Nithya Ramnath, MD
Principal Investigator
Roswell Park Cancer Institute
United States: Institutional Review Board
CDR0000562780
NCT00526890
October 2006
September 2010
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |