Status:
UNKNOWN
S-1 and Irinotecan Combination Chemotherapy for Advanced Gastric Cancer
Lead Sponsor:
Korean Cancer Study Group
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2008
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00343668
Start Date
September 1 2005
End Date
July 1 2008
Last Update
May 26 2010
Active Locations (7)
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1
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeolanam-do, South Korea, 519-809
2
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea, 561-712
3
Inha University hospital
Inchon, South Korea
4
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
Seoul, South Korea, 110-746