An Open-Label, Non-Randomized, Multicenter, Three Stage, Phase 2 Study of S-1 as 2 Line Therapy for Patients With Advanced Non-Small Cell Lung Cancer (Stage IIIB/Stage IV)
- Determine the antitumor activity of S-1 as second-line therapy, in terms of overall
response rate, in patients with unresectable or recurrent stage IIIB or IV non-small
cell lung cancer.
- Determine the duration of response, time to tumor progression, and overall survival of
patients treated with this drug.
- Determine the safety of this drug in these patients.
- Correlate S-1 plasma levels (components and metabolites) with safety and efficacy
parameters in patients treated with this drug.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Patients receive oral S-1 twice daily on days 1-14. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 weeks until progressive
disease and then every 2 months thereafter.
PROJECTED ACCRUAL: A total of 30-95 patients will be accrued for this study.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Overall response rate by CT scan and physical exam at the end of every even course or every 6 weeks until progressive disease (PD) or initiation of new anticancer therapy
Taiho Pharma U.S.A., Incorporated
United States: Federal Government
|New York Medical College||Valhalla, New York 10595|
|Siteman Cancer Center at Barnes-Jewish Hospital||Saint Louis, Missouri 63110|
|M.D. Anderson Cancer Center at University of Texas||Houston, Texas 77030|
|CCOP - Toledo Community Hospital||Toledo, Ohio 43623-3456|
|CCOP - Nevada Cancer Research Foundation||Las Vegas, Nevada 89109-2306|
|Mercy Cancer Center at Mercy Medical Center - North Iowa||Mason City, Iowa 50401|
|Consultants in Blood Disorders and Cancer||Louisville, Kentucky 40207|
|Fountain Valley, California 92708|
|Miami, Florida 33176|
|Florida Cancer Institute - New Port Richey||New Port Richey, Florida 34655|
|Associates in Oncology and Hematology||Chattanooga, Tennessee 37404|
|Charleston Cancer Center||Charleston, South Carolina 29406|
|Hematology Oncology Life Center||Alexandria, Louisiana 71301|
|Compassionate Cancer Care Medical Group Incorporated - Fountain Valley||Fountain Valley, California 92708|
|Western Hematology and Oncology Associates, PC||Lakewood, Colorado 80215|
|Northwestern Connecticut Oncology Hematology Associates - Sharon||Sharon, Connecticut 06069|
|Eastern Oncology Hematology||Greenville, North Carolina 27834|
|New Bern Cancer Care||New Bern, North Carolina 28560|
|Signal Point Hematology Oncology Incorporated||Middletown, Ohio 45042|
|Vita Hematology Oncology at St. Luke's Hospital||Bethlehem, Pennsylvania 18015|