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:
Collaborator:
Hokkaido University Hospital
Information provided by:
Hokkaido Gastrointestinal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00209677
First received: September 13, 2005
Last updated: October 31, 2007
Last verified: October 2007

September 13, 2005
October 31, 2007
December 2004
Not Provided
  • 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.
Same as current
Complete list of historical versions of study NCT00209677 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Phase I/II Study of Oral S-1 Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
Phase I/II Study of Oral S-1 Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
  • Drug: Gemcitabine
  • Drug: S-1
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
40
December 2007
Not Provided

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.
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00209677
HGCSG0405, GEMS-1
Yes
Not Provided
Hokkaido Gastrointestinal Cancer Study Group
Hokkaido University Hospital
Study Chair: Masahiro Asaka, MD, PhD Hokkaido Gastrointestinal Cancer Study Group
Hokkaido Gastrointestinal Cancer Study Group
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP