Head and Neck NeoplasmsPhase 2CECAVINCT01020864
Cetuximab in Combination With Chemotherapy for Patients With Head and Neck Cancer
A Phase 2 study testing Cetuximab, Carboplatin and Vinorelbine in people with Head and Neck Neoplasms, run by Per Pfeiffer at 1 site in Denmark.
Trial summary
This is an open, multicenter phase II study. The purpose is to demonstrate the efficacy of cetuximab in combination with carboplatin and vinorelbine as second line treatment in patients with recurrent or metastatic head and neck cancer who have progressed during or after treatment with first line cisplatinum. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Cetuximab, Carboplatin and Vinorelbine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2010to Jan 2012
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically verified squamous cell carcinoma of the head and neck where curatively intended local treatment is not possible.
- Measurable or non-measurable disease.
- Disease progression during or after first line palliative chemotherapy with cisplatinum or patients with recurrence < 6 months after primary concomitant chemo-radiotherapy with cisplatinum.
- WHO Performance Status 0-2.
- Age ≥ 18 years.
- Neutrophil count (ANC) ≥ 1.5 x 10^9/l and platelets ≥ 100 x 10^9/l.
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- Normal liver function with bilirubin < 1.5 x UNL (Upper Normal Limit), no UNL for ALAT with liver metastases.
- Creatinin clearance ≥ 50 ml/min.
- Signed informed consent.
Who cannot join
- Other active malignant disease.
- Patients who are considered unable to follow the treatment plan or follow-up visits.
- Other serious disease (e.g. severe heart disease, myocardial infarction (MI) within 1 year, active infection).
- Any condition or treatment which after the opinion of the investigator may expose the patient to a risk or may influence the purpose of the trial.
- Pregnant or lactating women.
- Known hypersensitivity towards one or more of the components of the treatment.
- Prior treatment with either cetuximab or other inhibitors of EGFR.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial of Cetuximab in Combination With Chemotherapy (Carboplatin and Navelbine) for Patients With Platinum-resistant Head and Neck Cancer
This is an open, multicenter phase II study. The purpose is to demonstrate the efficacy of cetuximab in combination with carboplatin and vinorelbine as second line treatment in patients with recurrent or metastatic head and neck cancer who have progressed during or after treatment with first line cisplatinum.
- Conditions
- Head and Neck Neoplasms
- Being tested
- Cetuximab, Carboplatin, Vinorelbine
- Keywords
- Platinum-resistent head and neck cancer, Cetuximab, Carboplatin, Navelbine, Phase II trial, Combination chemotherapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called Erbitux
Cetuximab 500 mg/m² i.v. day 1, every 2nd week
CarboplatinDrug
Carboplatin AUC = 3 i.v. day 1, every 21nd week
VinorelbineDrug
Vinorelbine 25 mg/m² i.v. day 1, every 2nd week
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Experimental | Patients will be treated with Cetuximab, Carboplatin and Vinorelbine i.v. day 1, every 2nd week.
Patients will be treated until progression and/or in case of unacceptable toxicity or if the patient wishes to stop treatment. Receives: Drug: Cetuximab; Drug: Carboplatin; Drug: Vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 2.5 years
Response rate
Measured: 3 years
Secondary outcomes (3)
Toxicity
Measured: 2.5 years
Median survival
Measured: 3 years
Correlation between response and evolvement in tumor biology markers.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2009 (estimated)
- Study startJan 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Per Pfeiffer
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Sponsor-investigator, Per Pfeiffer, Odense University Hospital
- Investigators
- Per Pfeiffer, Professor, MD, PhD, Study chair, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020864
- Sponsor's protocol ID
- 09.08
- Acronym
- CECAVI
- Status last verified
- Oct 2020
- First submitted
- 25 Nov 2009
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Cetuximab in Combination With Chemotherapy (Carboplatin and Navelbine) for Patients With Platinum-resistant Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT01020864
- Acronym / sponsor ID
- CECAVI / 09.08
- Conditions
- Head and Neck Neoplasms
- Keywords
- Platinum-resistent head and neck cancer, Cetuximab, Carboplatin, Navelbine, Phase II trial, Combination chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Per PfeifferUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- Jan 2010 (actual)
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 26 Nov 2009 (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.
This is an open, multicenter phase II study. The purpose is to demonstrate the efficacy of cetuximab in combination with carboplatin and vinorelbine as second line treatment in patients with recurrent or metastatic head and neck cancer who have progressed during or after treatment with first line cisplatinum.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Experimental | Drug: Cetuximab, Drug: Carboplatin, Drug: VinorelbinePatients will be treated with Cetuximab, Carboplatin and Vinorelbine i.v. day 1, every 2nd week. Patients will be treated until progression and/or in case of unacceptable toxicity or if the patient wishes to stop treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically verified squamous cell carcinoma of the head and neck where curatively intended local treatment is not possible.
- Measurable or non-measurable disease.
- Disease progression during or after first line palliative chemotherapy with cisplatinum or patients with recurrence < 6 months after primary concomitant chemo-radiotherapy with cisplatinum.
- WHO Performance Status 0-2.
- Age ≥ 18 years.
Key exclusion criteria (7 listed)
- Other active malignant disease.
- Patients who are considered unable to follow the treatment plan or follow-up visits.
- Other serious disease (e.g. severe heart disease, myocardial infarction (MI) within 1 year, active infection).
- Any condition or treatment which after the opinion of the investigator may expose the patient to a risk or may influence the purpose of the trial.
- Pregnant or lactating women.
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: ErbituxCetuximab 500 mg/m² i.v. day 1, every 2nd week | Drug | Chemotherapy |
| CarboplatinCarboplatin AUC = 3 i.v. day 1, every 21nd week | Drug | Chemotherapy |
| VinorelbineVinorelbine 25 mg/m² i.v. day 1, every 2nd week | Drug | Chemotherapy |
Primary outcome
Progression-free survival
Time frame: 2.5 years
Response rate
Time frame: 3 years
3 secondary outcomes
Toxicity
Time frame: 2.5 years
Median survival
Time frame: 3 years
Correlation between response and evolvement in tumor biology markers.
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
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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.
Per Pfeiffer, Professor, MD, PhD study chair
Odense 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, Carboplatin and Vinorelbine in people with Head and Neck Neoplasms, run by Per Pfeiffer at 1 site in Denmark.
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 9 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: withdrawn, as of the sponsor's last update on 2 Nov 2020. 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 Denmark. 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 was withdrawn before enrolling participants, so there are no results.
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 (time frame: 2.5 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 2 Nov 2020.