An Open Label, Non-Randomized, Multicenter, Three Stage, Phase 2 Study of S-1 in Combination With Cisplatin as 1st Line Therapy for Patients With Advanced Non-Small Cell Lung Cancer (Stage IIIB/Stage IV)
- Determine the antitumor activity, in terms of overall response rate, of S-1 and
cisplatin in patients with unresectable stage IIIB or IV non-small cell lung cancer.
- Determine the duration of response and time to progression in patients treated with
- Determine the safety profile of this regimen in these patients.
- Correlate the S-1 (components and metabolites) plasma levels with safety and efficacy
parameters in patients treated with this regimen.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Patients receive oral S-1 twice daily on days 1-14 and cisplatin IV over 1-3 hours on day 1.
Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or
After completion of study treatment, patients are followed every 6 weeks until disease
PROJECTED ACCRUAL: A total of 6-60 patients will be accrued to this study.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Overall response by CT scan and physical exam at the end of every even course of treatment until disease progression or the initiation of new anticancer therapy
Taiho Pharma U.S.A., Incorporated
United States: Federal Government
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Siteman Cancer Center at Barnes-Jewish Hospital||Saint Louis, Missouri 63110|
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia||Philadelphia, Pennsylvania 19107|
|University of New Mexico Cancer Research and Treatment Center||Albuquerque, New Mexico 87131|
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|
|M.D. Anderson Cancer Center at University of Texas||Houston, Texas 77030|
|CCOP - Nevada Cancer Research Foundation||Las Vegas, Nevada 89109-2306|
|New Mexico Cancer Care Associates||Santa Fe, New Mexico 87505-7670|
|Palm Beach Cancer Institute - West Palm Beach||West Palm Beach, Florida 33401|
|Fountain Valley, California 92708|
|Kenmar Research Institute||Los Angeles, California 90057|
|Lovelace Medical Center||Albuquerque, New Mexico 87108|
|Associates in Oncology and Hematology||Chattanooga, Tennessee 37404|
|Charleston Cancer Center||Charleston, South Carolina 29406|
|Hematology Oncology Associates, PC||Albuquerque, New Mexico 87106|
|Hematology Oncology Life Center||Alexandria, Louisiana 71301|
|Northwestern Connecticut Oncology Hematology Associates - Sharon||Sharon, Connecticut 06069|
|Signal Point Hematology Oncology Incorporated||Middletown, Ohio 45042|
|Vita Hematology Oncology at St. Luke's Hospital||Bethlehem, Pennsylvania 18015|