S-1 and Cisplatin as First-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery
Recruitment status was Active, not recruiting
RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving S-1 together with cisplatin works as first-line therapy in treating patients with stage III or stage IV non-small cell lung cancer that cannot be removed by surgery.
Drug: tegafur-gimeracil-oteracil potassium
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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)|
- 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 [ Designated as safety issue: No ]
- Duration of response by CT scan and physical exam every 6 weeks [ Designated as safety issue: No ]
- Progression-free survival by CT scan and physical exam every 6 weeks [ Designated as safety issue: No ]
- Safety by adverse events and laboratory evaluations at days 1, 8, and 15 of each course, EOS, periodically, and 30 days after treatment [ Designated as safety issue: Yes ]
|Study Start Date:||August 2005|
- 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 this regimen.
- 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 unacceptable toxicity.
After completion of study treatment, patients are followed every 6 weeks until disease progression.
PROJECTED ACCRUAL: A total of 6-60 patients will be accrued to this study.
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|Fountain Valley, California, United States, 92708|
|Gilroy, California, United States, 95020|
|Kenmar Research Institute|
|Los Angeles, California, United States, 90057|
|United States, Connecticut|
|Northwestern Connecticut Oncology Hematology Associates - Sharon|
|Sharon, Connecticut, United States, 06069|
|United States, Florida|
|Palm Beach Cancer Institute - West Palm Beach|
|West Palm Beach, Florida, United States, 33401|
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Louisiana|
|Hematology Oncology Life Center|
|Alexandria, Louisiana, United States, 71301|
|United States, Missouri|
|Siteman Cancer Center at Barnes-Jewish Hospital|
|Saint Louis, Missouri, United States, 63110|
|United States, Nevada|
|CCOP - Nevada Cancer Research Foundation|
|Las Vegas, Nevada, United States, 89106|
|United States, New Mexico|
|Hematology Oncology Associates, PC|
|Albuquerque, New Mexico, United States, 87106|
|Lovelace Medical Center|
|Albuquerque, New Mexico, United States, 87108|
|University of New Mexico Cancer Research and Treatment Center|
|Albuquerque, New Mexico, United States, 87131-5636|
|New Mexico Cancer Care Associates|
|Santa Fe, New Mexico, United States, 87505|
|United States, Ohio|
|Signal Point Hematology Oncology Incorporated|
|Middletown, Ohio, United States, 45042|
|United States, Pennsylvania|
|Vita Hematology Oncology at St. Luke's Hospital|
|Bethlehem, Pennsylvania, United States, 18015|
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19107-5541|
|United States, South Carolina|
|Charleston Cancer Center|
|Charleston, South Carolina, United States, 29406|
|United States, Tennessee|
|Associates in Oncology and Hematology|
|Chattanooga, Tennessee, United States, 37404|
|United States, Texas|
|M.D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Principal Investigator:||Dawn Buchanan||Taiho Pharma U.S.A., Incorporated|