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| Sponsored by: |
Fudan University |
|---|---|
| Information provided by: | Fudan University |
| ClinicalTrials.gov Identifier: | NCT00767377 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer |
Drug: EOF5 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Phase II Trial of Epirubicin, Oxaliplatin and 5-Day 5-Fluorouracil in Patients With Advanced and Metastatic Gastric Cancer |
| Estimated Enrollment: | 80 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Five day Continuous infusion of FU combined with Epirubicin and Oxaliplatin
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: xiaodong Zhu, M.D | 862164175590 ext 1105 | xddr001@163.com |
| China | |
| Fudan University Cancer Hospital | Recruiting |
| Shanghai, China, 200032 | |
| Contact: xiaodong Zhu, M.D 862164175590 ext 1105 xddr001@163.com | |
| Sub-Investigator: xiaodong Zhu, M.D | |
| Principal Investigator: | Jiliang Ying, M.D | Fudan University Cancer Hospital |
More Information
| Responsible Party: | Department of medical oncology, Cancer Hospital, Fuandan University ( Base for drug clinical trials, Fudan University cancer hospital ) |
| Study ID Numbers: | EOF-MGC |
| Study First Received: | October 6, 2008 |
| Last Updated: | October 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00767377 |
| Health Authority: | China: Ethics Committee |
|
Time to Progression Overall survival Response rate Quality of Live Toxicities |
|
Oxaliplatin Stomach Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Fluorouracil |
Stomach Neoplasms Disease Progression Gastrointestinal Neoplasms Stomach cancer Epirubicin |
|
Neoplasms Neoplasms by Site Antineoplastic Agents |
Therapeutic Uses Antibiotics, Antineoplastic Pharmacologic Actions |
