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

Tracking Information

• First Submitted Date: October 6, 2008
• First Posted Date: October 7, 2008
• Last Update Posted Date: October 16, 2013
• Study Start Date: May 2007
• Actual Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 27, 2011): Time to progression [ Time Frame: every six weeks ]
• Original Primary Outcome Measures (submitted: October 6, 2008): Time to progression [ Time Frame: every two cycles ]
• Current Secondary Outcome Measures (submitted: October 6, 2008): Toxicity [ Time Frame: 3 weeks ]
• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: September 21, 2013)

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.

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Continuous Infusion of FU Combined With Epirubicin and Oxaliplatin in Patients With A/MGC
• Official Title: Phase II Trial of Epirubicin, Oxaliplatin and 5-day 5-fluorouracil in Patients With Advanced and Metastatic Gastric Cancer
• 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.
• 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Gastric Cancer

Intervention

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

Study Arms

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.

Intervention: Drug: EOF5

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 21, 2013): 163
• Original Estimated Enrollment (submitted: October 6, 2008): 80
• Actual Study Completion Date: March 2013
• Actual Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT00767377
• Other Study ID Numbers: EOF-MGC
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Xiaodong Zhu, Fudan University
• Study Sponsor: Fudan University
• Collaborators: Not Provided

Investigators

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

• PRS Account: Fudan University
• Verification Date: October 2013