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Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Gastric Cancer

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Hokkaido Gastrointestinal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00209664
First received: September 13, 2005
Last updated: January 31, 2006
Last verified: January 2004
History of Changes
  Purpose

To assess the usefulness of irinotecan plus S-1 therapy based on the antitumor effect and survival period. by performing a phase 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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Gastric Cancer: Hokkaido Gastrointestinal Cancer Study Group HGCSG0303

Resource links provided by NLM:

U.S. FDA Resources

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, median survival time, and safety will also be assessed.

Estimated Enrollment: 40
Study Start Date: January 2004
Estimated Study Completion Date: December 2008
Detailed Description:

A multicenter Open-label, single-arm, phase 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:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209664

Locations
Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8638
Sponsors and Collaborators
Hokkaido Gastrointestinal Cancer Study Group
Investigators
Study Chair: Yoshito Komatsu, MD, PhD Hokkaido Gastrointestinal Cancer Study Group
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00209664     History of Changes
Other Study ID Numbers: HGCSG0303
Study First Received: September 13, 2005
Last Updated: January 31, 2006
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Irinotecan
Antineoplastic Agents, Phytogenic
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013