Status:
COMPLETED
Biweekly FOLFIRI in Advanced Gastric Cancer (AGC) With Failure of Prior Taxane, Fluoropyrimidine, and Cisplatin
Lead Sponsor:
Asan Medical Center
Conditions:
Advanced Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is: * To observe the feasibility of biweekly oxaliplatin and infusional 5-fluorouracil (FU)/Leucovorin (LV) in patients with advanced gastric adenocarcinoma who have prior e...
Detailed Description
There is presently no chemotherapy regimen considered to be the standard of care for patients with advanced gastric cancer. However, more and more patients will receive fluoropyrimidine, platinum, and...
Eligibility Criteria
Inclusion
- Pathologically proven non-resectable adenocarcinoma of stomach
- Measurable disease based on Response Criteria in Solid Tumors (RECIST)
- Prior chemotherapy with taxane, fluoropyrimidine, and cisplatinum in combination or sequentially, there is no time limit for the last chemotherapy
- Age 18 to 70 years old
- Estimated life expectancy of more than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower
- Adequate bone marrow function (white blood cell counts \>4,000/µL, absolute neutrophil count \[ANC\]\>1,500/µL, hemoglobin \>9.0 g/dL, and platelets\>100,000/µL),
- Adequate kidney function (creatinine\<1.5 mg/dL)
- Adequate liver function (bilirubin\<1.5 mg/dL , transaminases levels\<3 times the upper normal limit \[5 times for patients with liver metastasis\], and serum albumin of \>2.5 mg/dL)
Exclusion
- Other tumor type than adenocarcinoma
- Presence or history of central nervous system metastasis
- Obvious or impending bowel obstruction (including obvious peritoneal carcinomatosis)
- Evidence of active gastrointestinal bleeding
- Other serious illness or medical conditions
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00976768
Start Date
October 1 2004
End Date
December 1 2009
Last Update
January 7 2020
Active Locations (1)
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1
Asan medical center
Seoul, South Korea, 138-736