Phase I/II Study of Oral S-1 Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Registration Number
- NCT00209677
- Lead Sponsor
- Hokkaido Gastrointestinal Cancer Study Group
- 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)
🇯🇵Sapporo, Hokkaido, Japan
Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)🇯🇵Sapporo, Hokkaido, Japan