Phase I/II Study of SOL for Untreated Metastatic Colorectal Cancer
Recruitment status was: Active, not recruiting
S-1 is promising drug which could replace 5-fluorouracil plus l-leucovorin (5-FU/l-LV) in treatment of advanced colorectal cancer.
Phase I/II study of S-1 plus Oxaliplatin (SOX) demonstrated its promising activity with acceptable toxicity as first-line chemotherapy in patients with untreated metastatic colorectal cancer and S-1 showed equivalent possibility to 5-FU/l-LV. On the other hand, phase I/II study of S-1 plus oral Leucovorin (S-1/LV) demonstrated that this regimen had enhanced efficacy in comparison with S-1 alone. From these results, it was expected that S-1/LV plus Oxaliplatin (SOL) would be more effective than SOX.
Therefore, phase I/II study of SOL combination therapy was planned.
Purpose A dose-finding study of S-1/LV plus Oxaliplatin (SOL) was planned to determine the recommended dose (RD), and to assess the response rate (RR) in patients with untreated metastatic colorectal cancer. The primary endpoints of the phase I portion are determination of the RD of SOL, and safety.
The phase II portion of this study was aimed to assess the RR of SOL.
Drug: S-1, oral Leucovorin, Oxaliplatin
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of S-1, Oral Leucovorin, and Oxaliplatin Combination Therapy (SOL) in Patients With Untreated Metastatic Colorectal Cancer|
- Determine the RD of S-1, Leucovorin, and Oxaliplatin in phase I setting [ Time Frame: During 2 cycles ]
- Evaluate the response rate of S-1, Leucovorin, and Oxaliplatin with recommended dose in phase II [ Time Frame: During chemotherapy ]
- Phase I - Safety - Pharmacokinetic drug-drug interaction - Response rate - Time to treatment failure (TTF) - Progression free survival (PFS) - Overall survival (OS)
- Phase II - Safety - Time to treatment failure (TTF) - Progression free survival (PFS) - Overall survival (OS)
|Study Start Date:||August 2007|
|Estimated Study Completion Date:||April 2011|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00524706
|Shizuoka Cancer Center|
|Shizuoka, Japan, 411-8777|
|Principal Investigator:||Narikazu Boku, MD||Shizuoka Cancer Cener, Division of Gastrointestinal Oncology|