Gastric CancerPhase 2FLAGNCT00275951
Cetuximab Plus P-HDFL for the First-line Treatment of Advanced Gastric Cancer
A Phase 2 study testing Cetuximab Plus P-HDFL in people with Gastric Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Cetuximab Plus P-HDFL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2005to Jun 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Oncology, National Taiwan University Hospital
Taipei, 100
About this study
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
The investigators have initial evidence that the combination of cetuximab and cisplatin-HDFL may further improve the efficacy of the cisplatin-HDFL combination chemotherapy.
Read the 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.
- Conditions
- Gastric Cancer
- Being tested
- Cetuximab Plus P-HDFL
- Keywords
- Combination, Chemotherapy, Gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetuximab Plus P-HDFLDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cetuximab Plus P-HDFL | Experimental | 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. Receives: Drug: Cetuximab Plus P-HDFL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed objective response rates
Measured: Confirmed objective response within 4 weeks
Secondary outcomes (1)
Progression-free survival (PFS), overall survival (OS), treatment-related toxicity
Measured: 3 years and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2006 (estimated)
- Study startDec 2005
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan, National Health Research Institutes, Taiwan, Chang Gung Memorial Hospital, Tri-Service General Hospital (TSGH)
- Responsible party
- Sponsor
- Investigators
- Ann-Lii Cheng, M.D., Ph.D., Study chair, Department of Oncology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00275951
- Sponsor's protocol ID
- 941004
- Acronym
- FLAG
- Status last verified
- Nov 2012
- First submitted
- 11 Jan 2006
- Last updated
- 16 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00275951
- Acronym / sponsor ID
- FLAG / 941004
- Conditions
- Gastric Cancer
- Keywords
- Combination, Chemotherapy, Gastric cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan, National Health Research Institutes, Taiwan, Chang Gung Memorial Hospital, Tri-Service General Hospital (TSGH)
- Study start
- Dec 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 12 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cetuximab Plus P-HDFL | Experimental | Drug: Cetuximab Plus P-HDFLCetuximab 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetuximab Plus P-HDFLCetuximab 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 |
Primary outcome
Confirmed objective response rates
Time frame: Confirmed objective response within 4 weeks
1 secondary outcome
Progression-free survival (PFS), overall survival (OS), treatment-related toxicity
Time frame: 3 years and 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann-Lii Cheng, M.D., Ph.D. study chair
Department of Oncology, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab Plus P-HDFL in people with Gastric Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmed objective response rates (time frame: Confirmed objective response within 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2012; AzTrials last refreshed its copy on 7 Nov 2026.