A Phase I/II Trial of TS-1 and Oxaliplatin in Patients With Advanced Colorectal Cancer
Capecitabine and oxaliplatin(XELOX) is active first-line therapy for patients with metastatic colorectal cancer. Phase II study of TS-1, a novel oral fluoropyrimidine derivative, showed activity in patients with metastatic colorectal carcinoma. Preclinical data of TS-1 with oxaliplatin showed synergistic activity in vivo human colorectal cancer xenograft. There is no data about the optimal dose of TS-1 with 2 weeks schedule combined with oxaliplatin. Therefore in a phase I study, we would like to determine the maximum tolerated dose(MTD) of TS-1 and oxaliplatin and define the recommended dose for subsequent phase II study. And then, in a phase II study we would like to evaluate the efficacy(response rates) and toxicities of the new combination regimen in advanced colorectal cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Trial of TS-1 and Oxaliplatin in Patients With Advanced Colorectal Cancer|
- In a phase I study, to determine the maximum tolerated dose(MTD) In a phase II study, to evaluate the efficacy(response rates) and toxicities [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- To investigate the time to progression(TTP), overall survival and toxicity [ Time Frame: two year ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2006|
|Study Completion Date:||March 2009|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Drug: TS-1, oxaliplatin
Subjects meeting all of the following criteria will be considered for enrolment into the study.
- Histologically documented colorectal adenocarcinoma
- Previous chemotherapy up to two regimens(including adjuvant chemotherapy and first-line chemotherapy without oxaliplatin) is allowed in phase I portion; patients are required to have discontinued chemotherapy and/or radiotherapy for at least 4weeks before entry into phase I portion. No prior chemotherapy or radiotherapy allowed(adjuvant chemotherapy and/or radiotherapy would be allowed) in phase II portion
- Age 18 to 75 years old
- At least one unidimensional measurable lesion with a diameter >20 mm using conventional CT or MRI scans or >10 mm using spiral CT scans (use of spiral CT must be documented in medical records and used consistently throughout study).
- In phase I study, prior radiotherapy is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented, and provided it has been completed at least 4 weeks before study entry.
- Performance status (ECOG scale): 0-2
- Patients can take food and drugs orally
- Adequate organ functions
- Life expectancy ≥ 3 months
- Written informed consent
Please refer to this study by its ClinicalTrials.gov identifier: NCT00531245
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of, 135-710|
|Principal Investigator:||Young Suk Park, M.D., Ph.D.||Samsung Medical Center, Seoul, KOREA|