S-1 and Irinotecan Combination Chemotherapy for Advanced Gastric Cancer
A Phase II Study of S-1 and Irinotecan Combination Chemotherapy in Patients With Advanced Gastric Cancer as a First-Line Therapy
1 other identifier
interventional
44
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 gastric-cancer
Started Sep 2005
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 22, 2006
CompletedFirst Posted
Study publicly available on registry
June 23, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedMay 26, 2010
June 1, 2006
1.5 years
June 22, 2006
May 25, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
response rate
best response
Secondary Outcomes (1)
treatment-related toxicities
during treatment
Interventions
S-1, 40 mg/m2 PO twice daily, days 1-14 irinotecan, 150 mg/m2 IV, day 1
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeolanam-do, 519-809, South Korea
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 561-712, South Korea
Inha University hospital
Inchon, South Korea
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
Seoul, 110-746, South Korea
Yonsei Cancer Center
Seoul, 120-752, South Korea
Seoul Veterans Hospital
Seoul, 134-791, South Korea
Korea Institute of radiological and Medical Sciences
Seoul, 139-706, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Baek-Yeol Ryoo, M.D., Ph.D.
Korea Institute of Radiological and Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 22, 2006
First Posted
June 23, 2006
Study Start
September 1, 2005
Primary Completion
March 1, 2007
Study Completion
July 1, 2008
Last Updated
May 26, 2010
Record last verified: 2006-06