Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
Advanced Gastric Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

4 months

Safety Issue:

No

Authority:

Korea: Food and Drug Administration

Study ID:

AMC0501

NCT ID:

NCT00976768

Start Date:

October 2004

Completion Date:

December 2009

Related Keywords:

  • Advanced Gastric Cancer
  • Advanced gastric cancer
  • FOLFIRI
  • Stomach Neoplasms

Name

Location