Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Phase I/II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Gastric Cancer
This study has been completed.
Sponsored by: Hokkaido Gastrointestinal Cancer Study Group
Information provided by: Hokkaido Gastrointestinal Cancer Study Group
ClinicalTrials.gov Identifier: NCT00209638
  Purpose

To assess the usefulness of irinotecan 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 gastric cancer


Condition Intervention Phase
Gastric Cancer
Drug: irinotecan
Drug: S-1
Phase I
Phase II

MedlinePlus related topics: Cancer Stomach Cancer
Drug Information available for: Irinotecan Irinotecan hydrochloride S 1 (Combination)
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Phase I/II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Gastric Cancer: Hokkaido Gastrointestinal Cancer Study Group HGCSG0101

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

Primary Outcome Measures:
  • objective tumor response

Secondary Outcome Measures:
  • Response duration, time to progression, overall survival, and safety will also be assessed.

Estimated Enrollment: 24
Study Start Date: May 2000
Estimated Study Completion Date: April 2003
Detailed Description:

A multicenter Open-label, single-arm, phase I/II clinical trial is conducted on patients with histological stage IV gastric cancer given irinotecan plus S-1. The usefulness of this regimens as 1st line therapy for gastric cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

・ Eligibility criteria

  1. Histological diagnosis of gastric adenocarcinoma.
  2. Measurable or assessable lesions.
  3. Age: 18 ~ 75 years.
  4. Performance Status (ECOG): 0 ~ 2.
  5. No prior chemotherapy or only one regimen of previous chemotherapy (with a washout period >4 weeks after the final day of the previous therapy). Adjuvant chemotherapy is not defined as previous therapy.
  6. No history of treatment with CPT-11 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 12,000/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5times the upper limit of normal (excluding liver metastasis). T-Bil 2.0mg/dl. Creatinine <1.5 mg/dl (but if it is 1.0 ~ 1.5 mg/dl, the dose of S-1 can be decreased according to the dose reduction criteria to allow registration in the trial). 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. Diarrhea (watery stools).
  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. Gilbert’s syndrome.
  13. Judged to be ineligible for this protocol by the attending physician.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209638

Sponsors and Collaborators
Hokkaido Gastrointestinal Cancer Study Group
Investigators
Study Chair: Masahiro Asaka, MD, PhD Hokkaido Gastrointestinal Cancer Study Group
  More Information

Study ID Numbers: HGCSG0002
Study First Received: September 13, 2005
Last Updated: April 19, 2006
ClinicalTrials.gov Identifier: NCT00209638  
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Hokkaido Gastrointestinal Cancer Study Group:
Irinotecan,
S-1,
Phase I/II,
gastric cancer

Study placed in the following topic categories:
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Stomach Neoplasms
Irinotecan
Gastrointestinal Neoplasms
Stomach cancer

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009