Biweekly FOLFIRI in Advanced Gastric Cancer (AGC) With Failure of Prior Taxane, Fluoropyrimidine, and Cisplatin
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Progression-free survival [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Toxicity profile (according to National Cancer Institute Common Terminology Criteria for Adverse Event [NCI CTC AE] version 3.0) [ Time Frame: Each cycle of chemotherapy ] [ Designated as safety issue: Yes ]
- Response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2004|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Experimental: FOLFIRI arm
Patients receiving FOLFIRI
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)
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.