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

Asan Medical Center

Status and phase

Completed

Phase 2

Conditions

Advanced Gastric Cancer

Treatments

Drug: oxaliplatin, 5-fluorouracil

Study type

Interventional

Funder types

Other

Identifiers

NCT00976768

AMC0402

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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