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

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Cetuximab Plus P-HDFL
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Combination, Chemotherapy, Gastric cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Oncology, National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cetuximab Plus P-HDFL

Arm Description

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.

Outcomes

Primary Outcome Measures

Confirmed objective response rates

Secondary Outcome Measures

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

Full Information

First Posted
January 11, 2006
Last Updated
November 15, 2012
Sponsor
National Taiwan University Hospital
Collaborators
Taipei Veterans General Hospital, Taiwan, National Health Research Institutes, Taiwan, Chang Gung Memorial Hospital, Tri-Service General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00275951
Brief Title
Cetuximab Plus P-HDFL for the First-line Treatment of Advanced Gastric Cancer
Acronym
FLAG
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Taipei Veterans General Hospital, Taiwan, National Health Research Institutes, Taiwan, Chang Gung Memorial Hospital, Tri-Service General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Combination, Chemotherapy, Gastric cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cetuximab Plus P-HDFL
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cetuximab Plus P-HDFL
Intervention Description
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 Outcome Measure Information:
Title
Confirmed objective response rates
Time Frame
Confirmed objective response within 4 weeks
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS), overall survival (OS), treatment-related toxicity
Time Frame
3 years and 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann-Lii Cheng, M.D., Ph.D.
Organizational Affiliation
Department of Oncology, National Taiwan University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Oncology, National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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