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

NCT ID: NCT00595972

Last Updated: 2011-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2010-12-31

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

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

Group Type: EXPERIMENTAL

ECF-endostar

Intervention Type: DRUG

Epirubicin 50mg/M2 D1, Cisplatin 60mg/M2 D1, FU 500mg/M2 D1-5, endostar 7.5mg/M2 D1-14, treatment cycle repeat every 3 weeks. Treatment should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Interventions

ECF-endostar

Epirubicin 50mg/M2 D1, Cisplatin 60mg/M2 D1, FU 500mg/M2 D1-5, endostar 7.5mg/M2 D1-14, treatment cycle repeat every 3 weeks. Treatment should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Intervention Type: DRUG

Other Intervention Names

treatment group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Department of medical oncology, Cancer Hospital, Fuandan University

Principal Investigators

Jin Li, PhD, M.D

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

ECF/endo-MGC

Identifier Type: -

Identifier Source: org_study_id