Clinical trial · Interventional
Phase I/II Study of Oral S-1 Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
NCT00209677CI-TRIAL-00000942suspendedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unfortunately, other Phase III clinical Study (GEM+S-1 vs GEM vs S-1) have been started in Japan. h
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) in Phase I setting.
- measure
- Determine the clinical response rate with Recommended dose in Phase II setting.
Secondary outcomes (2)
- measure
- Determine the clinical response rate of patients in Phase I setting.
- measure
- Determine the MST(Median Survival Time) and DFS(Disease Free Survival) in Phase II setting.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.