Status:
SUSPENDED
Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Gastric Cancer
Lead Sponsor:
Hokkaido Gastrointestinal Cancer Study Group
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To assess the usefulness of irinotecan plus S-1 therapy based on the antitumor effect and survival period. by performing a phase II study of this combination in patients with inoperable or with postop...
Detailed Description
A multicenter Open-label, single-arm, phase II clinical trial is conducted on patients with histological stage IV gastric cancer given irinotecan plus S-1. The usefulness of this regimens as 1st line ...
Eligibility Criteria
Inclusion
- ・ Eligibility criteria
- Histological diagnosis of gastric adenocarcinoma.
- Measurable or assessable lesions.
- Age: 18 \~ 75 years.
- Performance Status (ECOG): 0 \~ 2.
- No prior chemotherapy or only one regimen of previous chemotherapy (with a washout period \>4 weeks after the final day of the previous therapy). Adjuvant chemotherapy is not defined as previous therapy.
- No history of treatment with CPT-11 or S-1.
- No history of radiotherapy to the abdomen.
- Oral intake of S-1 is possible.
- Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3 and 12,000/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5times the upper limit of normal (excluding liver metastasis). T-Bil 2.0mg/dl. Creatinine \<1.5 mg/dl (but if it is 1.0 \~ 1.5 mg/dl, the dose of S-1 can be decreased according to the dose reduction criteria to allow registration in the trial). Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes). (10) Predicted survival for \>3 months.
- (11) Able to give written informed consent
Exclusion
- \-
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00209664
Start Date
January 1 2004
End Date
December 1 2008
Last Update
February 2 2006
Active Locations (1)
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1
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8638