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Completed

NCT Number: NCT00275951

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

The investigators have initial evidence that the combination of cetuximab and cisplatin-HDFL may further improve the efficacy of the cisplatin-HDFL combination chemotherapy.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Oncology, National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 to 75 years
  • Histologically proven adenocarcinoma
  • At least one "measurable" lesion (by RECIST)
  • No prior chemotherapy for gastric cancer
  • WHO performance status ≦ 2
  • Adequate baseline organ functions
  • Fasting serum triglyceride level > 70 mg/dL
  • Written informed consent
  • At least one month from gastrectomy
  • Availability of tumor sample for immunohistochemical or pharmacogenomic testing of EGFR

Exclusion criteria

  • Concomitant anti-cancer biological agents, chemotherapy, or radiotherapy
  • CNS metastasis
  • Pregnancy, breast-feeding women and women of child-bearing potential
  • Life expectancy less 3 months
  • Serious concomitant illness
  • Concurrent or prior second malignancy
  • Known hypersensitivity reaction to any of the components of study treatments

Treatment and study plan

Cetuximab Plus P-HDFL

Drug

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.

Primary outcomes

  1. Confirmed objective response rates

    Time frame: Confirmed objective response within 4 weeks

Secondary outcomes

  1. Progression-free survival (PFS), overall survival (OS), treatment-related toxicity

    Time frame: 3 years and 5 years

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Chang Gung Memorial Hospital
  • National Health Research Institutes, Taiwan
  • Taipei Veterans General Hospital, Taiwan
  • Tri-Service General Hospital (TSGH)

Registry information

Official study 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

Acronym: FLAG

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Jan 12, 2006
Registry last updated
Nov 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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