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

This study has been completed.
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00595972
First received: January 4, 2008
Last updated: June 27, 2011
Last verified: September 2010
  Purpose

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).


Condition Intervention Phase
Gastric Cancer
Drug: ECF-endostar
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Epirubicin Cisplatin and FU Combined With Endostar in Patients With Advanced or Metastatic Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • time to progression [ Time Frame: every two cycles ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • toxicity [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: November 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
patients will be treated by ECF regimen (epirubicin, cisplatin plus 5-FU) combined with endostar
Drug: 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
Other Name: treatment group

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00595972

Locations
China, Shanghai
Fudan University Cancer Hospital
ShangHai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Jin Li, PhD, M.D Fudan University
  More Information

No publications provided

Responsible Party: Base for drug clinical trials, Fudan University cancer hospital, Department of medical oncology, Cancer Hospital, Fuandan University
ClinicalTrials.gov Identifier: NCT00595972     History of Changes
Other Study ID Numbers: ECF/endo-MGC
Study First Received: January 4, 2008
Last Updated: June 27, 2011
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
Time to Progression
Overall survival
Response rate
Quality of Live
Toxicities

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Cisplatin
Epirubicin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on April 17, 2014