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

This study has suspended participant recruitment.
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Unfortunately, other Phase III clinical Study (GEM+S-1 vs GEM vs S-1) have been started in Japan.

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Sponsor:
ClinicalTrials.gov Identifier:
NCT00209677
First Posted: September 21, 2005
Last Update Posted: November 1, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hokkaido University Hospital
Information provided by:
Hokkaido Gastrointestinal Cancer Study Group
  Purpose
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.

Condition Intervention Phase
Pancreatic Cancer Drug: Gemcitabine Drug: S-1 Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Oral S-1 Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Hokkaido Gastrointestinal Cancer Study Group:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 40
Study Start Date: December 2004
Estimated Study Completion Date: December 2007
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209677


Locations
Japan
Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)
Sapporo, Hokkaido, Japan, 060-8638
Sponsors and Collaborators
Hokkaido Gastrointestinal Cancer Study Group
Hokkaido University Hospital
Investigators
Study Chair: Masahiro Asaka, MD, PhD Hokkaido Gastrointestinal Cancer Study Group
  More Information

ClinicalTrials.gov Identifier: NCT00209677     History of Changes
Other Study ID Numbers: HGCSG0405
GEMS-1
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: November 1, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs