A Phase I Study of S-1 Plus Irinotecan and Oxaliplatin in Advanced Gastrointestinal Malignancy
- Sponsor
- National Cancer Center, Korea
- Study ID
- NCT00506207
- Phase
- PHASE1
- Status
- Unknown
Conditions
- Colorectal Neoplasm
- Gastric Neoplasm
- Secondary
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- S-1, Irinotecan, Oxaliplatin — DRUG
Study Details
This study is an open-label, single center, and a dose-escalating phase I study to determine the maximal tolerated dose and the recommended dose of S-1 combined with irinotecan/oxaliplatin in patients with unresectable or metastatic colorectal or gastric carcinoma.
Key Dates
- Start date
- Sep 30, 2006
- Status verified
- Jul 2007
- Completion
- Dec 31, 2009
Study Design
- Enrollment
- 23 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Primary Outcome Measure
Toxicity measured by NCICTC v.3 [ Time Frame: During treatment ]
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