A Phase I/II Trial of TS-1 and Oxaliplatin in Patients With Advanced Colorectal Cancer
Subjects meeting all of the following criteria will be considered for enrolment into the
study.
1. Histologically documented colorectal adenocarcinoma
2. 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
3. Age 18 to 75 years old
4. 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).
5. 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.
6. Performance status (ECOG scale): 0-2
7. Patients can take food and drugs orally
8. Adequate organ functions
9. Life expectancy ≥ 3 months
10. Written informed consent
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
one year
Yes
Young Suk Park, M.D., Ph.D.
Principal Investigator
Samsung Medical Center, Seoul, KOREA
Korea: Food and Drug Administration
2006-01-024
NCT00531245
August 2006
March 2009
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