Biweekly FOLFIRI in Advanced Gastric Cancer (AGC) With Failure of Prior Taxane, Fluoropyrimidine, and Cisplatin

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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 exposure to taxane, fluoropyrimidine, and cisplatin

• To determine the activity of this combination regimen.

• To evaluate the treatment-related toxicities.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Fluorouracil; Oxaliplatin; Taxane

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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