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Cetuximab Plus P-HDFL for the First-line Treatment of Advanced Gastric Cancer (FLAG)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00275951
First Posted: January 12, 2006
Last Update Posted: November 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Taipei Veterans General Hospital, Taiwan
National Health Research Institutes, Taiwan
Chang Gung Memorial Hospital
Tri-Service General Hospital
Information provided by (Responsible Party):
National Taiwan University Hospital
  Purpose
The investigators have initial evidence that the combination of cetuximab and cisplatin-HDFL may further improve the efficacy of the cisplatin-HDFL combination chemotherapy.

Condition Intervention Phase
Gastric Cancer Drug: Cetuximab Plus P-HDFL Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Confirmed objective response rates [ Time Frame: Confirmed objective response within 4 weeks ]

Secondary Outcome Measures:
  • Progression-free survival (PFS), overall survival (OS), treatment-related toxicity [ Time Frame: 3 years and 5 years ]

Enrollment: 39
Study Start Date: December 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cetuximab Plus P-HDFL
Cetuximab 400 mg/m2, IV, day 1 of cycle 1; then weekly IV 250 mg/m2. Cisplatin 24-hour IV infusion 35 mg/m2/day, plus HDFL (5-FU 2,000 mg/m2 and leucovorin 300 mg/m2), day 1 and day 8. HDFL IV, day 15.
Drug: Cetuximab Plus P-HDFL
Cetuximab 400 mg/m2, IV, day 1 of cycle 1; then weekly IV 250 mg/m2. Cisplatin 24-hour IV infusion 35 mg/m2/day, plus HDFL (5-FU 2,000 mg/m2 and leucovorin 300 mg/m2), day 1 and day 8. HDFL IV, day 15.

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00275951


Locations
Taiwan
Department of Oncology, National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Taipei Veterans General Hospital, Taiwan
National Health Research Institutes, Taiwan
Chang Gung Memorial Hospital
Tri-Service General Hospital
Investigators
Study Chair: Ann-Lii Cheng, M.D., Ph.D. Department of Oncology, National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00275951     History of Changes
Other Study ID Numbers: 941004
First Submitted: January 11, 2006
First Posted: January 12, 2006
Last Update Posted: November 16, 2012
Last Verified: November 2012

Keywords provided by National Taiwan University Hospital:
Combination
Chemotherapy
Gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Cisplatin
Cetuximab
Antineoplastic Agents