Status:

COMPLETED

Study of Cetuximab to Treat Gastric Cancer

Lead Sponsor:

Fudan University

Conditions:

Gastric Cancer

Eligibility:

All Genders

18-70 years

Phase:

PHASE2

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of cetuximab combined with FOLFIRI in patients with advanced gastric cancer who failed first-line chemotherapy

Detailed Description

Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have been suggested as the first line therapy for A/MGC by FDA, there is no standard regimen for patients with A...

Eligibility Criteria

Inclusion

  • Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
  • ECOG performance scale ≤ 1
  • 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

  • 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
  • Uncontrolled significant comorbid conditions and previous radiotherapy

Key Trial Info

Start Date :

May 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2009

Estimated Enrollment :

61 Patients enrolled

Trial Details

Trial ID

NCT00699881

Start Date

May 1 2008

End Date

October 1 2009

Last Update

December 23 2009

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China