Biweekly FOLFIRI in Advanced Gastric Cancer (AGC) With Failure of Prior Taxane, Fluoropyrimidine, and Cisplatin
|ClinicalTrials.gov Identifier: NCT00976768|
Recruitment Status : Completed
First Posted : September 14, 2009
Last Update Posted : January 14, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Gastric Cancer||Drug: oxaliplatin, 5-fluorouracil||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2004|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
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)
- Progression-free survival [ Time Frame: 4 months ]
- Overall survival [ Time Frame: 1 year ]
- 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 ]
- Response rate [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00976768
|Korea, Republic of|
|Asan medical center|
|Seoul, Korea, Republic of, 138-736|