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Phase I/II Study of Oral S-1 Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer

Phase 1/Phase 2
20 Years
75 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

Phase I/II Study of Oral S-1 Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer

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.

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) in Phase I setting.

Principal Investigator

Masahiro Asaka, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Hokkaido Gastrointestinal Cancer Study Group


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

December 2004

Completion Date:

December 2007

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms