Epirubicin Cisplatin and Fluorouracil (FU) Combined With Endostar in Patients With Advanced or Metastatic Gastric Cancer

Phase 2

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: ECF-endostar

• Registration Number: NCT00595972
• Lead Sponsor: Fudan University

Brief Summary

The purpose of this study is to evaluate the efficacy and tolerability of the ECF regimen (epirubicin, cisplatin and FU) combined with endostar-- a inhibitor of angiogenesis, in patients with advanced or metastatic gastric cancer (A/MGC).

Detailed Description

Although there is no standard regimen in the treatment of metastatic gastric cancer, ECF regimen (epirubicin, cisplatin and FU) is often considered as a reference regimen. And ECF regimen has been suggested as the first line therapy for A/MGC by FDA. According to the result of a Chinese phase III clinical trial in metastatic lung cancer, endostar-- a new angiogenesis inhibitor prolonged the overall survival, time to progression and improved response rate. So we designed this clinical trial to evaluate whether endostar can bring survival benefits to patients with advanced and metastatic gastric cancer patients.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-01-04
• Study First Submitted QC: 2008-01-15
• Study First Posted: 2008-01-16
• Status Verified: 2010-09
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Last Update Submitted: 2011-06-27
• Last Update Posted: 2011-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	ECF-endostar	patients will be treated by ECF regimen (epirubicin, cisplatin plus 5-FU) combined with endostar

Primary Outcome Measures

Name	Time	Method
time to progression	every two cycles

Secondary Outcome Measures

Name	Time	Method
toxicity	3 weeks

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 ShangHai, Shanghai, China