S-1 and Irinotecan Combination Chemotherapy for Advanced Gastric Cancer
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
advanced gastric cancer, First-line therapy, S-1, irinotecan
Study Type
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: S-1, irinotecan
Type: Drug
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
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

- Active uncontrolled infection

- Other serious underlying medical conditions which could impair the ability of the patient to participate in the study

- Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy

- concomitant drug medication; The following drugs cause drug interaction with S-1.

i. Warfarin, phenprocoumon: increase bleeding tendency ii. Increase blood concentration of phenytoin iii. sorivudine: inhibit DPD -> increase toxicity according to fluoropyrimidine iv. allopurinol : decrease activity of S-1
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeolanam-do, Korea, Republic of
Status: Recruiting
Contact: Sang Hee Cho, M.D., Ph.D. - +82-61-379-7633 - sh115@chollian.net
Chonbuk National University Hospital
Jeonju, Jeonbuk, Korea, Republic of
Status: Not yet recruiting
Contact: Eun Kee Song, M.D. - +82-63-250-1245 - eksong@chonbuk.ac.kr
Inha University hospital
Inchon, Korea, Republic of
Status: Not yet recruiting
Contact: Moon Hee Lee, M.D., Ph.D. - +82-32-890-2583 - moonhlmd@inha.ac.kr
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: Seung Sei Lee, M.D., Ph.D. - +82-2-2001-2084 - llssss.lee@samsung.com
Korea Institute of radiological and Medical Sciences
Seoul, Korea, Republic of
Status: Recruiting
Contact: Baek-Yeol Ryoo, M.D., Ph.D. - +82-2-970-1208 - ryooby@kcch.re.kr
Seoul Veterans Hospital
Seoul, Korea, Republic of
Status: Not yet recruiting
Contact: Bong-Seog Kim, M.D., Ph.D. - +82-2-2225-1319 - seog@e-bohun.or.kr
Yonsei Cancer Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Hyun Cheol Chung, M.D., Ph.D. - +82-2-2228-8132 - unchung8@yumc.yonsei.ac.kr
Start Date
September 2005
Completion Date
July 2008
Korean Cancer Study Group
Korean Cancer Study Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page