A Phase II Study of S-1 and Irinotecan Combination Chemotherapy in Patients With Advanced Gastric Cancer as a First-Line Therapy

Korean Cancer Study Group7 sites in 1 country44 target enrollmentSeptember 2005

ConditionsGastric Cancer

DrugsS-1, irinotecan

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Gastric Cancer
Sponsor: Korean Cancer Study Group
Enrollment: 44
Locations: 7
Primary Endpoint: response rate
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary goal of this phase II trial is to evaluate the response rate of combination chemotherapy with S-1 and Irinotecan in patients with advanced gastric cancer as a first-line therapy.

Registry

clinicaltrials.gov

Start Date

September 2005

End Date

July 2008

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Korean Cancer Study Group

Eligibility Criteria

Inclusion Criteria

•Pathologically proven unresectable adenocarcinoma of stomach
•With uni-dimensionally measurable disease (at least longest diameter 2 cm on conventional CT scan, x-ray or physical examination, or 1cm on spiral CT scan)
•Age 18 to 70 years old
•Estimated life expectancy of more than 3 months
•ECOG performance status of 2 or lower
•Adequate bone marrow function(absolute neutrophil count \[ANC\] ≥1,500/µL, hemoglobin ≥9.0 g/dL,and platelets ≥100,000/µL)
•Adequate kidney function (serum creatinine \< 1.5 mg/dL)
•Adequate liver function (serum total bilirubin \< 2 times the upper normal limit (UNL); serum transaminases levels \<3 times \[\<5 times for patients with liver metastasis\] UNL)
•No prior chemotherapy but prior adjuvant chemotherapy finished at least 6 months before enrollment was allowed. (but, prior adjuvant chemotherapy with capecitabine or S-1 or camptothecin analogues was excluded)
•No prior radiation therapy for at least 4 weeks before enrollment in the study

Exclusion Criteria

•Other tumor type than adenocarcinoma
•Central nervous system (CNS) metastases or prior radiation for CNS metastases
•Gastric outlet obstruction or intestinal obstruction
•Evidence of gastrointestinal bleeding
•The patient has bony lesions as the sole evaluable disease.
•Past or concurrent history of neoplasm other than stomach cancer, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
•Pregnant or lactating women, women of childbearing potential not employing adequate contraception
•Other serious illness or medical conditions
•Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
•History of significant neurologic or psychiatric disorders including dementia or seizures