Back to resultsEpirubicin Cisplatin and Fluorouracil (FU) Combined With Endostar in Patients With Advanced or Metastatic Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
ECF-endostar
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Time to Progression, Overall survival, Response rate, Quality of Live, Toxicities
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
Sites / Locations
- Fudan University Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
patients will be treated by ECF regimen (epirubicin, cisplatin plus 5-FU) combined with endostar
Outcomes
Primary Outcome Measures
time to progression
Secondary Outcome Measures
toxicity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00595972
Brief Title
Epirubicin Cisplatin and Fluorouracil (FU) Combined With Endostar in Patients With Advanced or Metastatic Gastric Cancer
Official Title
Phase II Trial of Epirubicin Cisplatin and FU Combined With Endostar in Patients With Advanced or Metastatic Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Time to Progression, Overall survival, Response rate, Quality of Live, Toxicities
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
patients will be treated by ECF regimen (epirubicin, cisplatin plus 5-FU) combined with endostar
Intervention Type
Drug
Intervention Name(s)
ECF-endostar
Other Intervention Name(s)
treatment group
Intervention Description
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
Primary Outcome Measure Information:
Title
time to progression
Time Frame
every two cycles
Secondary Outcome Measure Information:
Title
toxicity
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Li, PhD, M.D
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
ShangHai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Learn more about this trial
Epirubicin Cisplatin and Fluorouracil (FU) Combined With Endostar in Patients With Advanced or Metastatic Gastric Cancer
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