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

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00275951
First received: January 11, 2006
Last updated: November 15, 2012
Last verified: November 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

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.
Other Name: Cetuximab Plus P-HDFL

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00275951     History of Changes
Other Study ID Numbers: 941004
Study First Received: January 11, 2006
Last Updated: November 15, 2012
Health Authority: Taiwan: Department of Health

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
Cetuximab
Cisplatin
Leucovorin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 01, 2014