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

Sponsor

Hokkaido Gastrointestinal Cancer Study Group (Other)

Overall Status

Completed

CT.gov ID

NCT00209638

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Drug: irinotecan Drug: S-1	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2000

Study Completion Date :

Apr 1, 2003

Outcome Measures

Primary Outcome Measures

objective tumor response []

Secondary Outcome Measures

Response duration, time to progression, overall survival, and safety will also be assessed. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

・ Eligibility criteria

Histological diagnosis of gastric adenocarcinoma.
Measurable or assessable lesions.
Age: 18 ~ 75 years.
Performance Status (ECOG): 0 ~ 2.
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.
No history of treatment with CPT-11 or S-1.
No history of radiotherapy to the abdomen.
Oral intake of S-1 is possible.
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).
Predicted survival for >3 months.
Able to give written informed consent

Exclusion Criteria:

Severe pleural effusion or ascites.
Metastasis to the central nervous system (CNS).
Active gastrointestinal bleeding.
Active infection.
Diarrhea (watery stools).
Uncontrolled ischemic heart disease.
Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
Active multiple cancer.
Severe mental disorder.
Pregnancy, possible pregnancy, or breast-feeding.
Flucytosine treatment
Gilbert's syndrome.
Judged to be ineligible for this protocol by the attending physician.