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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Cisplatin; Endostar protein; Epirubicin

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