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

April 19, 2006 updated by: Hokkaido Gastrointestinal Cancer Study Group

Phase I/II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Gastric Cancer: Hokkaido Gastrointestinal Cancer Study Group HGCSG0101

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

24

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
objective tumor response

Secondary Outcome Measures

Outcome Measure
Response duration, time to progression, overall survival, and safety will also be assessed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hokkaido Gastrointestinal Cancer Study Group

Investigators

  • Study Chair: Masahiro Asaka, MD, PhD, Hokkaido Gastrointestinal Cancer Study Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2000

Study Completion

April 1, 2003

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

April 21, 2006

Last Update Submitted That Met QC Criteria

April 19, 2006

Last Verified

April 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGCSG0002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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