Advanced Gastric Cancer
Conditions
Keywords
Advanced gastric cancer, FOLFIRI
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 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.
Interventions
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)
Sponsors
Asan Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 1 year |
| Toxicity profile (according to National Cancer Institute Common Terminology Criteria for Adverse Event [NCI CTC AE] version 3.0) | Each cycle of chemotherapy |
| Response rate | 6 months |
Countries
South Korea
Outcome results
None listed