Lung Cancer Clinical Trial
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
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.
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.
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