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

NCT00209677 | Suspended Phase 1 DMC

• 2 other identifiers: HGCSG0405GEMS-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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.

Interventions

Gemcitabine DRUG

S-1 DRUG

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hokkaido Gastrointestinal Cancer Study Group: lead
• Hokkaido University Hospital: collaborator

Study Sites (1)

Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)

Sapporo, Hokkaido, 060-8638, Japan

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; S 1 (combination)

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Masahiro Asaka, MD, PhD

  Hokkaido Gastrointestinal Cancer Study Group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: December 1, 2004
• Study Completion: December 1, 2007
• Last Updated: November 1, 2007

Record last verified: 2007-10

Locations

JP (1)