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Phase II Trial of Epirubicin Cisplatin and FU Combined With Endostar in Patients With Advanced or Metastatic Gastric Cancer


Phase 2
18 Years
70 Years
Not Enrolling
Both
Gastric Cancer

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Trial Information

Phase II Trial of Epirubicin Cisplatin and FU Combined With Endostar in Patients With Advanced or Metastatic Gastric Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

time to progression

Outcome Time Frame:

every two cycles

Safety Issue:

Yes

Principal Investigator

Jin Li, PhD, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Ethics Committee

Study ID:

ECF/endo-MGC

NCT ID:

NCT00595972

Start Date:

November 2007

Completion Date:

December 2010

Related Keywords:

  • Gastric Cancer
  • Time to Progression
  • Overall survival
  • Response rate
  • Quality of Live
  • Toxicities
  • Stomach Neoplasms

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