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Phase II Study of Cetuximab Plus P-HDFL(Cisplatin and Weekly 24-Hour Infusion of High-dose 5-Fluorouracil and Leucovorin)for the First-line Treatment of Advanced Gastric Cancer


Phase 2
18 Years
75 Years
Not Enrolling
Both
Gastric Cancer

Thank you

Trial Information

Phase II Study of Cetuximab Plus P-HDFL(Cisplatin and Weekly 24-Hour Infusion of High-dose 5-Fluorouracil and Leucovorin)for the First-line Treatment of Advanced Gastric Cancer


The clinical efficacy (confirmed objective response rates, progression-free survival,
overall survival), and treatment-related toxicities of this novel regimen will be examined
as the first-line treatment in patients with nonresectable or recurrent/metastatic gastric
cancer.


Inclusion Criteria:



1. Age 18 to 75 years

2. Histologically proven adenocarcinoma

3. At least one "measurable" lesion (by RECIST)

4. No prior chemotherapy for gastric cancer

5. WHO performance status ≦ 2

6. Adequate baseline organ functions

7. Fasting serum triglyceride level > 70 mg/dL

8. Written informed consent

9. At least one month from gastrectomy

10. Availability of tumor sample for immunohistochemical or pharmacogenomic testing of
EGFR

Exclusion Criteria:

1. Concomitant anti-cancer biological agents, chemotherapy, or radiotherapy

2. CNS metastasis

3. Pregnancy, breast-feeding women and women of child-bearing potential

4. Life expectancy less 3 months

5. Serious concomitant illness

6. Concurrent or prior second malignancy

7. Known hypersensitivity reaction to any of the components of study treatments

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:

Confirmed objective response rates

Outcome Time Frame:

Confirmed objective response within 4 weeks

Safety Issue:

No

Principal Investigator

Ann-Lii Cheng, M.D., Ph.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Oncology, National Taiwan University Hospital

Authority:

Taiwan: Department of Health

Study ID:

941004

NCT ID:

NCT00275951

Start Date:

December 2005

Completion Date:

June 2009

Related Keywords:

  • Gastric Cancer
  • Combination
  • Chemotherapy
  • Gastric cancer
  • Stomach Neoplasms

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