S-1 and Irinotecan Combination Chemotherapy for Advanced Gastric Cancer
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
advanced gastric cancer, First-line therapy, S-1, irinotecan
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: S-1, irinotecan
Type: Drug
Overall Status
Recruiting
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.
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
Locations
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
Sponsors
Korean Cancer Study Group
Source
Korean Cancer Study Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page