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

Advanced Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00976768
• Other study ID #: AMC0402
• Status: Completed
• Phase: Phase 2
• Start date: October 2004
• Est. completion date: December 2009

Study information

• Verified date: January 2020
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Gastric Cancer
• Stomach Neoplasms

Intervention

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)

Locations

Country	Name	City	State
Korea, Republic of	Asan medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		4 months
Secondary	Overall survival		1 year
Secondary	Toxicity profile (according to National Cancer Institute Common Terminology Criteria for Adverse Event [NCI CTC AE] version 3.0)		Each cycle of chemotherapy
Secondary	Response rate		6 months