Status:
SUSPENDED
Phase I/II Study of Oral S-1 Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
Lead Sponsor:
Hokkaido Gastrointestinal Cancer Study Group
Collaborating Sponsors:
Hokkaido University Hospital
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
20-75 years
Phase:
PHASE1
PHASE2
Brief Summary
To assess the usefulness of Gemcitabine plus S-1 therapy based on the antitumor effect and survival period. By performing a phase I/II study of this combination in patients with inoperable or with pos...
Detailed Description
A multicenter Open-label, single-arm, phase I/II clinical trial is conducted on patients with histological stage IV Pancreatic cancer given gemcitabine plus S-1. The usefulness of this regimens as 1st...
Eligibility Criteria
Inclusion
- Histological diagnosis of pancreatic adenocarcinoma.
- Measurable or assessable lesions(Except for Phase I).
- Age: 20 \~ 75 years.
- Kar-nofsky Performance Status (KPS) \> 70.
- No prior chemotherapy
- No history of treatment with gemcitabine 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 Neutrophil 2,000/mm3. Hb 9.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5 times the upper limit of normal (excluding liver metastasis). T-Bil 2.0 mg/dl. Creatinine within the upper limit of normal). Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes).
- Predicted survival for \>3 months.
- Able to give written informed consent.
Exclusion
- Severe pleural effusion or ascites.
- Metastasis to the central nervous system (CNS).
- Active gastrointestinal bleeding.
- Active infection.
- Liver cirrhosis
- Uncontrolled ischemic heart disease.
- Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
- Active multiple cancer.
- Severe mental disorder.
- Pregnancy, possible pregnancy, or breast-feeding.
- Flucytosine treatment
- Judged to be ineligible for this protocol by the attending physician.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00209677
Start Date
December 1 2004
End Date
December 1 2007
Last Update
November 1 2007
Active Locations (1)
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1
Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)
Sapporo, Hokkaido, Japan, 060-8638