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

• ClinicalTrials.gov Identifier: NCT00767377
• Recruitment Status: Completed
• First Posted: October 7, 2008
• Last Update Posted: October 16, 2013
• Sponsor: Fudan University
• Information provided by (Responsible Party): Xiaodong Zhu, Fudan University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Gastric Cancer	Drug: EOF5	Phase 2

Detailed Description:

ECF regimen is considered as a reference regimen for gastric cancer in Europe. Now, no regimen has been proved to be more effective while less toxicity than ECF regimen. Oxaliplatin has demonstrated synergy with 5-FU in vitro, in vivo, and in the clinical setting in advanced colorectal cancer. It presents a better toxicity profile than cisplatin. Recently some studies used combination regimens of oxaliplatin, folinic acid, and continuous infusion 5-FU for about 44 hours (e.g FOLFOX4 ) to treat A/MGC, and yielded good response rates and median overall survival times while resulting in lower rates of grade 3-4 adverse events. Therefore, it is logical to modify ECF regimen with oxaliplatin replacing cisplatin and a short-term FU infusion replacing 21-day FU infusion. Our objective is to evaluate whether the EOF5 regimen is less toxicity while is comparable effective as ECF regimen.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 163 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of Epirubicin, Oxaliplatin and 5-day 5-fluorouracil in Patients With Advanced and Metastatic Gastric Cancer
• Study Start Date: May 2007
• Actual Primary Completion Date: July 2012
• Actual Study Completion Date: March 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: EOF5 Group; 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; 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; Other Name: treatment group

Outcome Measures

Primary Outcome Measures :

1. Time to progression [ Time Frame: every six weeks ]

Secondary Outcome Measures :

1. Toxicity [ Time Frame: 3 weeks ]

Other Outcome Measures:

1. PET Scan response [ Time Frame: 14 days ]
   Patients enrolled in this trial would received 18F-FLT PET SACN and 18F-FDG PET SACN before and 14 days after the first cycle chemotherapy respectively.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Contacts and Locations

Locations

China

Fudan University Cancer Hospital

Shanghai, China, 200032

Sponsors and Collaborators

Fudan University

Investigators

• Principal Investigator: Jiliang Ying, M.D; Fudan University

More Information

• Responsible Party: Xiaodong Zhu, associated professor, Fudan University
• ClinicalTrials.gov Identifier: NCT00767377
• Other Study ID Numbers: EOF-MGC
• First Posted: October 7, 2008
• Last Update Posted: October 16, 2013
• Last Verified: October 2013

Keywords provided by Xiaodong Zhu, Fudan University:

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

Additional relevant MeSH terms:

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