Head and Neck CancerPhase 2EPICNCT00468169
Cetuximab (ERBITUX®) Added to Two Concurrent Chemoradiotherapy Platforms in Locally Advanced Head and Neck Cancer
A Phase 2 study testing Cetuximab, 5-FU and Hydroxyurea in people with Head and Neck Cancer, run by University of Chicago at 1 site in United States.
Trial summary
The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®) added to two concurrent chemoradiotherapy platforms of different intensity in locally advanced head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Cetuximab, 5-FU and Hydroxyurea
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Nov 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Stage III and IV head and neck cancer
- Patients with squamous cell carcinoma of unknown primary and suspected origin in the head and neck area
- No prior chemotherapy or radiotherapy
- Prior surgical therapy of incisional or excisional biopsy and organ-sparing procedures only
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- Normal organ and marrow function
Who cannot join
- Unequivocal demonstration of metastatic disease
- Known severe hypersensitivity to drugs used in the study
- Treatment with a non-approved or investigational drug within 30 days before Day 1
- Incomplete healing from previous surgery
- Pregnancy or breast feeding
- Uncontrolled intercurrent illness including
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- Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF
- Acute hepatitis or known HIV
- Severe baseline neurologic deficits
- Prior therapy which specifically and directly targets the EGFR pathway
- Prior severe infusion reaction to a monoclonal antibody
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase II Trial of Concurrent Chemoradiation With Cetuximab (ERBITUX®), 5 Fluorouracil, Hydroxyurea, and Twice-daily Radiation (CetuxFHX) Versus Cetuximab (ERBITUX®), Cisplatin, and Accelerated Radiation With Concomitant Boost (CetuxPX) After Induction Chemotherapy in Patients With Locally Advanced Head and Neck Cancer
The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®) added to two concurrent chemoradiotherapy platforms of different intensity in locally advanced head and neck cancer.
- Conditions
- Head and Neck Cancer
- Keywords
- Cetuximab, Erbitux, locally, advanced, head, neck, cancer, neoplasms, squamous, carcinoma, lymphoepithelioma
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called Erbitux (R)
250mg/m2(day 1, weekly x 10);
5-FUDrug
600 mg/m2/day; days 0-5 (120 h total) every other week x 5
HydroxyureaDrug
500 mg PO BID, days 0-5 every other week x 5
Twice-daily radiationRadiation
150 cGy per fraction, days 1-5, every other week x 5 (total duration 10 weeks)
CisplatinDrug
100 mg/m2, week 1 and 4 on day 1 (or 2)
Accelerated fraction radiotherapy with concomitant boostRadiation
72 Gy/42 F/6 W (3-D or IMRT based). Total duration 7 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A: Cetuximab+FHX | Experimental | Cetuximab [250mg/m2 (day 1, weekly x10)] + FHX (5-FU [CI: 600mg/m2/day; days 0-5 (120h total) every other week x5], Hydroxyurea [500 mg PO BID, days 0-5 (=11 doses), every other week x5] and twice-daily radiation [150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)]). Total duration is 10 weeks. Receives: Drug: Cetuximab; Drug: 5-FU; Drug: Hydroxyurea; Radiation: Twice-daily radiation |
| B: Cetuximab + PX | Experimental | Cetuximab [250 mg/m2 (day 1, weekly x7)] + PX (Cisplatin [100mg/m2 (week 1 \& 4 on day 1 (or 2))], Accelerated fraction radiotherapy with concomitant boost [AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)]). Total duration: 7 weeks. Receives: Drug: Cetuximab; Drug: Cisplatin; Radiation: Accelerated fraction radiotherapy with concomitant boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Kaplan-Meier estimate of PFS at 1 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: 1 years
Progression Free Survival (PFS)
Time from randomization until disease progression or death from any cause. Kaplan-Meier estimate of PFS at 2 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: 2 years
Secondary outcomes (4)
Overall Survival (OS)
Time from randomization until death from any cause. Kaplan-Meier estimate of OS at 2 years.
Measured: 2 years
Objective Response Rate to Induction
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: Post-Induction (8 weeks)
Objective Response Rate to CRT
Response to CRT was assessed by determining whether there was evidence of residual disease in the primary site via radiographic and clinical examination.
Measured: From date of chemoradiotherapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 weeks
Residual Lymph Node Disease
Response to CRT was also assessed by determining if there was evidence of residual lymph node disease by neck dissection, if warranted by the presence of any radiographically large (>1.5 cm) or focally abnormal lymph node.
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2007 (estimated)
- Study startJul 2006
- Primary completionAug 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Everett E Vokes, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468169
- Sponsor's protocol ID
- 14401A
- Acronym
- EPIC
- Status last verified
- Sep 2019
- First submitted
- 30 Apr 2007
- Last updated
- 9 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Concurrent Chemoradiation With Cetuximab (ERBITUX®), 5 Fluorouracil, Hydroxyurea, and Twice-daily Radiation (CetuxFHX) Versus Cetuximab (ERBITUX®), Cisplatin, and Accelerated Radiation With Concomitant Boost (CetuxPX) After Induction Chemotherapy in Patients With Locally Advanced Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00468169
- Acronym / sponsor ID
- EPIC / 14401A
- Conditions
- Head and Neck Cancer
- Keywords
- Cetuximab, Erbitux, locally, advanced, head, neck, cancer, neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jul 2006
- Primary completion
- Aug 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 2 May 2007 (estimated)
- Results
- Posted 9 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®) added to two concurrent chemoradiotherapy platforms of different intensity in locally advanced head and neck cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Cetuximab+FHX | Experimental | Drug: Cetuximab, Drug: 5-FU, Drug: Hydroxyurea, Radiation: Twice-daily radiationCetuximab [250mg/m2 (day 1, weekly x10)] + FHX (5-FU [CI: 600mg/m2/day; days 0-5 (120h total) every other week x5], Hydroxyurea [500 mg PO BID, days 0-5 (=11 doses), every other week x5] and twice-daily radiation [150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)]). Total duration is 10 weeks. |
| B: Cetuximab + PX | Experimental | Drug: Cetuximab, Drug: Cisplatin, Radiation: Accelerated fraction radiotherapy with concomitant boostCetuximab [250 mg/m2 (day 1, weekly x7)] + PX (Cisplatin [100mg/m2 (week 1 \& 4 on day 1 (or 2))], Accelerated fraction radiotherapy with concomitant boost [AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)]). Total duration: 7 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 or older
- Stage III and IV head and neck cancer
- Patients with squamous cell carcinoma of unknown primary and suspected origin in the head and neck area
- No prior chemotherapy or radiotherapy
- Prior surgical therapy of incisional or excisional biopsy and organ-sparing procedures only
Key exclusion criteria (11 listed)
- Unequivocal demonstration of metastatic disease
- Known severe hypersensitivity to drugs used in the study
- Treatment with a non-approved or investigational drug within 30 days before Day 1
- Incomplete healing from previous surgery
- Pregnancy or breast feeding
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 |
|---|---|---|
| CetuximabAlso: Erbitux (R)250mg/m2(day 1, weekly x 10); | Drug | A: Cetuximab+FHX, B: Cetuximab + PX |
| 5-FU600 mg/m2/day; days 0-5 (120 h total) every other week x 5 | Drug | A: Cetuximab+FHX |
| Hydroxyurea500 mg PO BID, days 0-5 every other week x 5 | Drug | A: Cetuximab+FHX |
| Twice-daily radiation150 cGy per fraction, days 1-5, every other week x 5 (total duration 10 weeks) | Radiation | A: Cetuximab+FHX |
| Cisplatin100 mg/m2, week 1 and 4 on day 1 (or 2) | Drug | B: Cetuximab + PX |
| Accelerated fraction radiotherapy with concomitant boost72 Gy/42 F/6 W (3-D or IMRT based). Total duration 7 weeks. | Radiation | B: Cetuximab + PX |
Primary outcome
Progression Free Survival (PFS)
Time frame: 1 years
Kaplan-Meier estimate of PFS at 1 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Progression Free Survival (PFS)
Time frame: 2 years
Time from randomization until disease progression or death from any cause. Kaplan-Meier estimate of PFS at 2 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
4 secondary outcomes
Overall Survival (OS)
Time frame: 2 years
Objective Response Rate to Induction
Time frame: Post-Induction (8 weeks)
Objective Response Rate to CRT
Time frame: From date of chemoradiotherapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 weeks
Residual Lymph Node Disease
Time frame: Up to 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Everett E Vokes, MD principal investigator
University of Chicago
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, 5-FU and Hydroxyurea in people with Head and Neck Cancer, run by University of Chicago at 1 site in United States.
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 7 inclusion and 11 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 9 Oct 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 9 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression Free Survival (PFS) (time frame: 1 years). The study lists 2 primary outcomes in all. 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 9 Oct 2019; AzTrials last refreshed its copy on 7 Nov 2026.