JPRN-C000000450
Completed
Phase 1
Phase I/II study on combination therapy consisting of a fixed dose-rate infusion of gemcitabine with oral fluorinated pyrimidine compound S-1 (FGS) in patients with gemcitabine-refractory advanced pancreatic cancer - Phase I/II study on combination therapy consisting of a fixed dose-rate infusion of gemcitabine with S-1 (FGS) in patients with gemcitabine-refractory advanced pancreatic cancer
ational Cancer Center Hospital, Hepatobiliary and Pancreatic Oncology Division0 sites40 target enrollmentJuly 20, 2006
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with gemcitabine-refractory metastatic pancreatic cancer
- Sponsor
- ational Cancer Center Hospital, Hepatobiliary and Pancreatic Oncology Division
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\)Regular use of fenitoin, warfarin or frucitocin 2\)History of fluorinated pyrimidine use 3\)Severe diarrhea 4\)Severe mental disorder 5\)Severe infection 6\)Severe complication 7\)Intestinal pneumonia or lung fibrosis 8\)History of chest radiotherapy 9\)Massive pleural or abdominal effusion 10\)Symptomatic brain metastasis 11\)History of other active malignancy 12\)Pregnancy or the desire to preserve fecundity 13\)Inadequate physical condition, as diagnosed by primary physician
Outcomes
Primary Outcomes
Not specified
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