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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00209638

Enrollment

Registered

2005-09-21

Start date

2000-05-31

Completion date

2003-04-30

Last updated

2006-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

Irinotecan,, S-1,, Phase I/II,, gastric cancer

Brief summary

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

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.

Interventions

DRUGirinotecan

DRUGS-1

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
objective tumor response	—

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026