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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00209677
• Other study ID #: HGCSG0405
• Secondary ID: GEMS-1
• Status: Suspended
• Phase: Phase 1/Phase 2
• First received: September 13, 2005
• Last updated: October 31, 2007
• Start date: December 2004
• Est. completion date: December 2007

Study information

• Verified date: October 2007
• Source: Hokkaido Gastrointestinal Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Gemcitabine

• S-1

Locations

Country	Name	City	State
Japan	Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)	Sapporo	Hokkaido

Sponsors (2)

Lead Sponsor	Collaborator
Hokkaido Gastrointestinal Cancer Study Group	Hokkaido University Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) in Phase I setting.
Primary	Determine the clinical response rate with Recommended dose in Phase II setting.
Secondary	Determine the clinical response rate of patients in Phase I setting.
Secondary	Determine the MST(Median Survival Time) and DFS(Disease Free Survival) in Phase II setting.