An Open-Label, Non-Randomized, Multicenter, Two-Stage, Phase 2 Study of S-1 as 2 Line Therapy for Patients With Metastatic Pancreatic Cancer
- Determine the antitumor activity of S-1 as second-line therapy, in terms of overall
response rate, in patients with metastatic pancreatic cancer previously treated with
- Determine the duration of response, time to tumor progression, and overall survival
rate in patients treated with this drug.
- Correlate changes in CA 19-9 with antitumor activity of this drug in these patients.
- Determine the effect of this drug on the clinical benefit parameters in these patients.
- Determine the safety of this drug in these patients.
- Correlate plasma drug levels with safety and efficacy of this drug in these patients.
OUTLINE: This is an open-label, non-randomized, 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 for up to 6 months.
PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Overall tumor response by CT (with contrast) of the chest, abdomen, and pelvis and physical exam at the end of every even course or every 6 weeks for up to 6 months
Taiho Pharma U.S.A., Incorporated
United States: Federal Government
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|University of New Mexico Cancer Research and Treatment Center||Albuquerque, New Mexico 87131|
|M.D. Anderson Cancer Center at University of Texas||Houston, Texas 77030|
|Broward General Medical Center Cancer Center||Ft. Lauderdale, Florida 33316|
|Comprehensive Cancer Institute||Huntsville, Alabama 35801|
|Helen and Harry Gray Cancer Center at Hartford Hospital||Hartford, Connecticut 06102-5037|
|Mercy Cancer Center at Mercy Medical Center - North Iowa||Mason City, Iowa 50401|
|Saint Louis University Cancer Center||Saint Louis, Missouri 63110|
|Consultants in Blood Disorders and Cancer||Louisville, Kentucky 40207|
|New Mexico Cancer Care Associates||Santa Fe, New Mexico 87505-7670|
|U.T. Cancer Institute at University of Tennessee Medical Center||Knoxville, Tennessee 37920-2911|
|Palm Beach Cancer Institute - West Palm Beach||West Palm Beach, Florida 33401|
|Fountain Valley, California 92708|
|Lovelace Medical Center||Albuquerque, New Mexico 87108|
|Florida Cancer Institute - New Port Richey||New Port Richey, Florida 34655|
|Hematology Oncology Associates, PC||Albuquerque, New Mexico 87106|
|Associates in Oncology and Hematology - Medical Center Drive||Rockville, Maryland 20878|
|Cancer Center of Indiana||New Albany, Indiana 47150|
|Mary Crowley Medical Research Center at Sammons Cancer Center||Dallas, Texas 75246|
|H. Clay Evans Johnson Cancer Center at Memorial Hospital||Chattanooga, Tennessee 37404|
|Compassionate Cancer Care Medical Group Incorporated - Fountain Valley||Fountain Valley, California 92708|
|Western Hematology and Oncology Associates, PC||Lakewood, Colorado 80215|
|Eastern Oncology Hematology||Greenville, North Carolina 27834|
|New Bern Cancer Care||New Bern, North Carolina 28560|
|Signal Point Hematology Oncology Incorporated||Middletown, Ohio 45042|
|East Bay Medical Oncology Hematology Associates||Concord, California 94520|