Pancreatic Cancer
Conditions
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 postoperative pancreatic cancer.
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 line therapy for pancreatic cancer was evaluated by the disease-free survival(DFS), median survival time (MST), incidence and severity of adverse event.
Interventions
DRUGGemcitabine
DRUGS-1
Sponsors
Hokkaido University Hospital
Hokkaido Gastrointestinal Cancer Study Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Histological diagnosis of pancreatic adenocarcinoma. 2. Measurable or assessable lesions(Except for Phase I). 3. Age: 20 \ 75 years. 4. Kar-nofsky Performance Status (KPS) \> 70. 5. No prior chemotherapy 6. No history of treatment with gemcitabine or S-1. 7. No history of radiotherapy to the abdomen. 8. Oral intake of S-1 is possible. 9. 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). 10. Predicted survival for \>3 months. 11. Able to give written informed consent.
Exclusion criteria
1. Severe pleural effusion or ascites. 2. Metastasis to the central nervous system (CNS). 3. Active gastrointestinal bleeding. 4. Active infection. 5. Liver cirrhosis 6. Uncontrolled ischemic heart disease. 7. Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure). 8. Active multiple cancer. 9. Severe mental disorder. 10. Pregnancy, possible pregnancy, or breast-feeding. 11. Flucytosine treatment 12. Judged to be ineligible for this protocol by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) in Phase I setting. | — |
| Determine the clinical response rate with Recommended dose in Phase II setting. | — |
Secondary
| Measure | Time frame |
|---|---|
| Determine the clinical response rate of patients in Phase I setting. | — |
| Determine the MST(Median Survival Time) and DFS(Disease Free Survival) in Phase II setting. | — |
Countries
Japan
Outcome results
None listed