Continuous Infusion of FU Combined With Epirubicin and Oxaliplatin in Patients With A/MGC

NCT00767377 | Completed Phase 2

• 1 other identifier: EOF-MGC
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and tolerability of the combination of epirubicin, oxaliplatin and 5-day continuous infusional 5-fluorouracil (EOF5 regimen) in patients with unresectable advanced or metastatic gastric cancer (A/MGC). Since Mar 2011, two addition second endpoints was added to the trial, one was to compare the consistence of two types of PET Scan evaluation with routine CT Scan evaluation, the other was to search for predictor factors of clinical results ( ORR,PFS and OS) with Pharmacogenomics methods. This modification was approved by the Ethic Committee of Fudan University Cancer Hospital, and the approval number was IRB50-15-1101A.

Conditions

Gastric Cancer

Keywords

Time to Progression; Overall survival; Response rate; Quality of Live; Toxicities

Outcome Measures

Primary Outcomes (1)

• Time to progression

  every six weeks

Secondary Outcomes (1)

• Toxicity

  3 weeks

Other Outcomes (1)

• PET Scan response

  14 days

Study Arms (1)

EOF5 Group

EXPERIMENTAL

The regimen of 5-day Continuous infusion of FU combined with Epirubicin and Oxaliplatin will be used in the patients recruited in this trial.

Drug: EOF5

Interventions

EOF5 DRUG

epirubicin 50 mg/m2 day 1, oxaliplatin 130 mg/m2 day 1, and 5-FU 375-425 mg/m2/d day 1 through 5 continuous infusion, repeated every 3 weeks

Also known as: treatment group

EOF5 Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
• ECOG performance scale ≤2
• At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
• Adequate hepatic, renal, heart, and hematologic functions (platelets \>80×109/L, neutrophil\>2.0×109/L, serum creatinine ≤1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase≤2.5×the ULN)

You may not qualify if:

• Pregnant or lactating women
• Concurrent cancer
• History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
• Neuropathy, brain, or leptomeningeal involvement
• Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia
• Uncontrolled significant comorbid conditions and previous radiotherapy

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Jiliang Ying, M.D

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associated professor

Study Record Dates

• First Submitted: October 6, 2008
• First Posted: October 7, 2008
• Study Start: May 1, 2007
• Primary Completion: July 1, 2012
• Study Completion: March 1, 2013
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

CN (1)