NCT00976768

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

A Phase II Study of Biweekly Oxaliplatin and 5-Fluorouracil/Leucovorin Combination Chemotherapy (FOLFIRI) in Patients With Advanced Gastric Cancer (AGC) With Failure of Prior Chemotherapy Including Taxane, Fluoropyrimidine and Cisplatinum

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 taxane combination or sequential chemotherapy. Unfortunately, about half of the patients receiving chemotherapy are unresponsive and treatment results of salvage chemotherapy are unsatisfactory. For these patients, there are currently no established palliative chemotherapy options, and there is urgent need for novel, active, and less toxic regimens for patients with advanced gastric cancer failing front-line chemotherapy. On these bases, we will investigate the activity of biweekly oxaliplatin and 5-FU/LV in patients with advanced gastric cancer who failed prior taxane, fluoropyrimidine and cisplatin chemotherapy.

Conditions

• Advanced Gastric Cancer

Interventions

Type	Name	Description
DRUG	oxaliplatin, 5-fluorouracil	Oxaliplatin 85 mg/㎡ IV, day 1 over 2 hours 5-FU 400 mg/㎡ IV bolus day 1 followed by 5-fluorouracil(FU) 2,400 mg/㎡ and leucovorin (LV) 100 mg/㎡ IV continuous over 46 hours (every 2 weeks)

Timeline

• Start date: 2004-10-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-09-14
• Last updated: 2020-01-07

Locations

1 site across 1 country: South Korea