Phase II Study of S-1 Plus LV (1 Week on and 1 Week Off) as First-line Treatment for Patients With Metastatic Colorectal Cancer
Phase 2
20 Years
N/A
20 Years
N/A
Not Enrolling
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
Phase II Study of S-1 Plus LV (1 Week on and 1 Week Off) as First-line Treatment for Patients With Metastatic Colorectal Cancer
Inclusion Criteria:
- Histologically proved adenocarcinoma
- Unresectable and recurrent colorectal cancer
- Age20 ≤ at enrollment
- Performance status 0 or 1 (ECOG)
- No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to
advanced disease. Patients who received adjuvant chemotherapy more than 180 days
before enrollment can be allowed but those who received S-1 containing treatment
shall be excluded
- Adequate hematologic, hepatic and renal functions
- At least one measurable lesion by RECIST criteria
Exclusion Criteria:
- Serious drug hypersensitivity
- Pregnant or nursing
- Bleeding from gastrointestinal tract
- Diarrhea
- Simultaneously active double cancer
- Serious illness or medical condition
- Brain metastasis
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Response Rate (ORR)
Outcome Time Frame:
During chemotherapy
Safety Issue:
No
Principal Investigator
Hideo Baba, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Graduate School of Medical Sciences Kumamoto University
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
Taiho10020400
NCT ID:
NCT00891332
Start Date:
October 2008
Completion Date:
November 2011
Related Keywords:
- Colorectal Cancer
- Colorectal Neoplasms
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