Head and Neck CancerPhase 1/2NCT00401401
Zalutumumab in Combination With Chemotherapy and Radiotherapy in Head and Neck Cancer
A Phase 1/2 study testing zalutumumab, cisplatin and Radiotherapy in people with Head and Neck Cancer and Squamous Cell Cancer, run by Genmab at 7 sites in 5 countries.
Trial summary
The purpose of this study is to investigate the safety of zalutumumab in combination with chemotherapy and radiotherapy as treatment of patients with 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, Squamous Cell Cancer
- What is being tested?
- zalutumumab, cisplatin and Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesin 5 countries
- Study dates
- Dec 2006to Oct 2010
- Phase
- Phase 1/2
- 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
- Patients with locoregionally advanced squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
Who cannot join
- Prior treatment with radiotherapy in the head and neck area
- Prior treatment with chemotherapy
- Prior treatment with similar drugs (e.g. EGFr antibodies, EGFr inhibitors)
- Previous surgery with curative intent for head and neck cancer
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Belgium2 sites
St-Luc University Hospital
Brussels
University Hospital Gasthuisberg
Leuven
France2 sites
Centre Georges-Francois Leclerc Hospital
Dijon
Hopital Bretonneau Clinique d'Oncologie et Radiothérapie
Tours
United States1 site
Oregon Health Sciences Center
Portland, Oregon, 97239
About this study
Official title: An Open-labeled Trial With a Dose-escalation Part and a Parallel Group Design(1) Investigating Zalutumumab, an Anti-EGF Receptor Antibody, in Combination With Chemo-Radiation as First Line Treatment of Patients With Cancer of the Head and Neck (1) The Parallel Group Part Was Cancelled
The purpose of this study is to investigate the safety of zalutumumab in combination with chemotherapy and radiotherapy as treatment of patients with head and neck cancer
- Conditions
- Head and Neck Cancer, Squamous Cell Cancer
- Being tested
- zalutumumab, cisplatin, Radiotherapy
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zalutumumabDrug
Eight weekly infusions
cisplatinDrug
Infusions
RadiotherapyProcedure or surgery
Daily in the treatment period
| Study group | Role | What they receive |
|---|---|---|
| Zalutumumab 4 mg/kg | Experimental | Zalutumumab 8 weekly infusions Receives: Drug: zalutumumab; Drug: cisplatin; Procedure: Radiotherapy |
| Zalutumumab 8 mg/kg | Experimental | Zalutumumab 8 weekly infusions Receives: Drug: zalutumumab; Drug: cisplatin; Procedure: Radiotherapy |
| Zalutumumab 12 mg/kg | Experimental | Zalutumumab 8 weekly infusions Receives: Drug: zalutumumab; Drug: cisplatin; Procedure: Radiotherapy |
| Zalutumumab 16 mg/kg | Experimental | Zalutumumab 8 weekly infusions Receives: Drug: zalutumumab; Drug: cisplatin; Procedure: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of participants with at least one adverse event. All adverse events were collected during the 8 week treatment period and the following 4 weeks. Serious adverse events were collected during 3 years after the patient was allocated to the trial.
Measured: Overall Study
Secondary outcomes (3)
Overall Response
Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR
Measured: Up to 3 years
Time to Response
Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR
Measured: Up to 3 years
Best Overall Tumor Response
Tumour response according to RECIST criteria J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2006 (estimated)
- Study startDec 2006
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: MTD was established and patients completed 16 months safety f-up and response assessments. It is considered of limited value to follow patients for 3 years.
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 GenmabThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genmab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vincent Gregoire, MD professor, Principal investigator, St-Luc University Hospital, Brussels, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401401
- Sponsor's protocol ID
- Hx-EGFr-203
- Status last verified
- Nov 2011
- First submitted
- 17 Nov 2006
- Last updated
- 23 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-labeled Trial With a Dose-escalation Part and a Parallel Group Design(1) Investigating Zalutumumab, an Anti-EGF Receptor Antibody, in Combination With Chemo-Radiation as First Line Treatment of Patients With Cancer of the Head and Neck (1) The Parallel Group Part Was Cancelled
- ClinicalTrials.gov ID
- NCT00401401
- Acronym / sponsor ID
- Hx-EGFr-203
- Conditions
- Head and Neck Cancer, Squamous Cell Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: MTD was established and patients completed 16 months safety f-up and response assessments. It is considered of limited value to follow patients for 3 years.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GenmabIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 20 Nov 2006 (estimated)
- Results
- Posted 23 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the safety of zalutumumab in combination with chemotherapy and radiotherapy as treatment of patients with head and neck cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Zalutumumab 4 mg/kg | Experimental | Drug: zalutumumab, Drug: cisplatin, Procedure: RadiotherapyZalutumumab 8 weekly infusions |
| Zalutumumab 8 mg/kg | Experimental | Drug: zalutumumab, Drug: cisplatin, Procedure: RadiotherapyZalutumumab 8 weekly infusions |
| Zalutumumab 12 mg/kg | Experimental | Drug: zalutumumab, Drug: cisplatin, Procedure: RadiotherapyZalutumumab 8 weekly infusions |
| Zalutumumab 16 mg/kg | Experimental | Drug: zalutumumab, Drug: cisplatin, Procedure: RadiotherapyZalutumumab 8 weekly infusions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with locoregionally advanced squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
Key exclusion criteria (4 listed)
- Prior treatment with radiotherapy in the head and neck area
- Prior treatment with chemotherapy
- Prior treatment with similar drugs (e.g. EGFr antibodies, EGFr inhibitors)
- Previous surgery with curative intent for head and neck cancer
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 |
|---|---|---|
| zalutumumabEight weekly infusions | Drug | Zalutumumab 12 mg/kg, Zalutumumab 16 mg/kg, Zalutumumab 4 mg/kg, Zalutumumab 8 mg/kg |
| cisplatinInfusions | Drug | Zalutumumab 12 mg/kg, Zalutumumab 16 mg/kg, Zalutumumab 4 mg/kg, Zalutumumab 8 mg/kg |
| RadiotherapyDaily in the treatment period | Procedure or surgery | Zalutumumab 12 mg/kg, Zalutumumab 16 mg/kg, Zalutumumab 4 mg/kg, Zalutumumab 8 mg/kg |
Primary outcome
Adverse Events
Time frame: Overall Study
Number of participants with at least one adverse event. All adverse events were collected during the 8 week treatment period and the following 4 weeks. Serious adverse events were collected during 3 years after the patient was allocated to the trial.
3 secondary outcomes
Overall Response
Time frame: Up to 3 years
Time to Response
Time frame: Up to 3 years
Best Overall Tumor Response
Time frame: Up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
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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.
Vincent Gregoire, MD professor principal investigator
St-Luc University Hospital, Brussels, Belgium
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing zalutumumab, cisplatin and Radiotherapy in people with Head and Neck Cancer and Squamous Cell Cancer, run by Genmab at 7 sites in 5 countries.
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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 23 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium, France, United States, Netherlands, Sweden. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 23 Dec 2011). 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?
Adverse Events (time frame: Overall Study). 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 23 Dec 2011.