Recurrent Head and Neck CancerPhase 2ORL03NCT01620242
A Phase II, Open-Label, Multicenter Trial of Cabazitaxel in Patients With Recurrent or Metastatic Head and Neck Cancer After Failure Of Cisplatin, Cetuximab and Taxanes
A Phase 2 study testing Cabazitaxel in people with Recurrent Head and Neck Cancer and Metastatic Head and Neck Cancer, run by UNICANCER at 5 sites in France.
Trial summary
This is a multi-center phase II study assessing whether cabazitaxel could be efficient for treatment of recurrent or metastatic head and neck cancer after failure of cisplatin, cetuximab and taxanes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Head and Neck Cancer, Metastatic Head and Neck Cancer
- What is being tested?
- Cabazitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 5 sitesFrance
- Study dates
- Apr 2012to 27 May 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic or recurrent Head and neck cancer
- Progression after cisplatin, cetuximab and taxanes (drugs could have been administered alone or in combination) given for recurrent/metastatic disease
- Age ≥ 18
- ECOG performance status ≤ 2
- At least one measurable lesion on CT-scan (as per RECIST criteria V1.1).
- Life expectancy ≥ 3 months
Show all 12Show fewer
- Adequate hematologic function (neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L; Hb ≥ 9.0 g/dL), renal function (clearance creatinine using the CKD-EPI formula (Chronic Kidney Disease Epidemiology group) ≥ 60 mL/min) and hepatic function (serum bilirubin ≤ 1 ULN; AST and ALT ≤ 2.5 x ULN).
- Potentially reproductive patients must agree to use an effective contraceptive method while on treatment, beginning 2 weeks before the first dose of investigational product and for 6 months after the final dose of investigational product.
- Women of childbearing potential must have a negative serum beta-HCG pregnancy test within 14 days prior of enrolment and/or urine pregnancy test within 48 hours before the first administration of the study treatment.
- Patients must be affiliated to a Social Security System.
- Patient who have received the information sheet and signed the informed consent form.
- Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
Who cannot join
- Active concurrent malignancy
- Progression in the 3 months after the completion of treatment for localized disease
- Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as :
- infection,
- cardiac disease such as uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within one year, LVEF > grade 2,
- current active hepatic or biliary disease (with exception of subjects with Gilbert's syndrome, asymptomatic gallstones, liver metastasis or stable chronic liver disease per investigator assessment),
Show all 19Show fewer
- renal disease,
- active GI tract ulceration, malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with active, uncontrolled ulcerative colitis are also excluded,
- severely impaired lung function (spirometry and DLCO 70% or less of normal and O2 saturation of 88% or less at rest on room air).
- Patients must have recovered of previous toxicity of chemotherapy and must not have toxicity grade > 1 ; grade ≥ 2 for neuropathy and grade ≥ 2 for cutaneous rash after cetuximab (in the CTCAE v4.0)
- Hypersensitivity to cabazitaxel, to other taxanes, or to any excipients of the formulation including polysorbate 80
- Pregnant women, women who are likely to become pregnant or are breast-feeding.
- Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- Patients who received any other investigational drugs within the 14 days prior to the start of cabazitaxel.
- Patients receiving radiation within 4 weeks prior to the first dose of study drug.
- Patients already included in another therapeutic trial involving an experimental drug
- Individual deprived of liberty or placed under the authority of a tutor.
- Other primary tumors within the previous 3 years
- Concomitant prohibited treatment. Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5. A one week wash-out period is necessary for patients who are already on these treatments.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre Oscar Lambret
Lille, 59020
Centre Léon Berard
Lyon, 69008
Centre Antoine Lacassagne
Nice, 06189
Institut Curie
Paris, 75231
Institut Gustave Roussy
Villejuif, 94805
About this study
Official title: A PHASE II, OPEN-LABEL, MULTICENTER TRIAL OF CABAZITAXEL IN PATIENTS WITH RECURRENT OR METASTATIC HEAD AND NECK CANCER AFTER FAILURE OF CISPLATIN, CETUXIMAB AND TAXANES.
This is a multi-center phase II study assessing whether cabazitaxel could be efficient for treatment of recurrent or metastatic head and neck cancer after failure of cisplatin, cetuximab and taxanes.
Read the detailed description
Patients will be treated with intravenous cabazitaxel 25 mg/m2 every 3 weeks (D1=D22) for 6 cycles.
In absence of progression disease or unacceptable toxicity, the treatment could be continued until a maximum of 10 cycles.
Disease response will be assessed every 6 weeks (i.e. every 2 cycles) clinically and by CT-scan.
An interim analysis will be carried out after the inclusion of the first 10 eligible and assessable patients.
- Being tested
- Cabazitaxel
- Keywords
- recurrent or metastatic head and neck cancer, cabazitaxel
- Medical subject headings
- Head and Neck Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabazitaxelDrug
25 mg/m2 every 3 weeks by IV administration
| Study group | Role | What they receive |
|---|---|---|
| Cabazitaxel | Experimental | All patients are treated with Cabazitaxel. Receives: Drug: Cabazitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
non-progression at 6 weeks
To assess the efficacy of cabazitaxel in terms of non-progression at 6 weeks for the treatment of recurrent or metastatic head and neck cancer after failure of cisplatin, cetuximab and taxanes.
Non-progression will be assessed after centralized review of CT-scans.
Measured: 6 weeks
Secondary outcomes (3)
progression free survival
Measured: 1-year
Toxicity according to NCI-CTCAE v4.0
Measured: from the first dose up to 30 days after the last dose
Quality of life evaluated by the QLQ-C30 and H&N35 questionnaire
Measured: at the inclusion, at 6 weeks and at the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionJun 2013
- Study completion27 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by UNICANCERThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620242
- Sponsor's protocol ID
- UC-0130/1106
- Other IDs
- 2011-004712-32
- Acronym
- ORL03
- Status last verified
- Feb 2021
- First submitted
- 24 May 2012
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: IPD will not be shared at an individual level, those data will be part of the study database including all enrolled patients.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE II, OPEN-LABEL, MULTICENTER TRIAL OF CABAZITAXEL IN PATIENTS WITH RECURRENT OR METASTATIC HEAD AND NECK CANCER AFTER FAILURE OF CISPLATIN, CETUXIMAB AND TAXANES.
- ClinicalTrials.gov ID
- NCT01620242
- Acronym / sponsor ID
- ORL03 / UC-0130/1106
- Keywords
- recurrent or metastatic head and neck cancer, cabazitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- 27 May 2014 (actual)
- First posted
- 15 Jun 2012 (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 a multi-center phase II study assessing whether cabazitaxel could be efficient for treatment of recurrent or metastatic head and neck cancer after failure of cisplatin, cetuximab and taxanes.
Detailed description
Patients will be treated with intravenous cabazitaxel 25 mg/m2 every 3 weeks (D1=D22) for 6 cycles.
In absence of progression disease or unacceptable toxicity, the treatment could be continued until a maximum of 10 cycles.
Disease response will be assessed every 6 weeks (i.e. every 2 cycles) clinically and by CT-scan.
An interim analysis will be carried out after the inclusion of the first 10 eligible and assessable patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cabazitaxel | Experimental | Drug: CabazitaxelAll patients are treated with Cabazitaxel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Metastatic or recurrent Head and neck cancer
- Progression after cisplatin, cetuximab and taxanes (drugs could have been administered alone or in combination) given for recurrent/metastatic disease
- Age ≥ 18
- ECOG performance status ≤ 2
- At least one measurable lesion on CT-scan (as per RECIST criteria V1.1).
Key exclusion criteria (19 listed)
- Active concurrent malignancy
- Progression in the 3 months after the completion of treatment for localized disease
- Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as :
- Patients must have recovered of previous toxicity of chemotherapy and must not have toxicity grade > 1 ; grade ≥ 2 for neuropathy and grade ≥ 2 for cutaneous rash after cetuximab (in the CTCAE v4.0)
- Hypersensitivity to cabazitaxel, to other taxanes, or to any excipients of the formulation including polysorbate 80
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 |
|---|---|---|
| Cabazitaxel25 mg/m2 every 3 weeks by IV administration | Drug | Cabazitaxel |
Primary outcome
non-progression at 6 weeks
Time frame: 6 weeks
To assess the efficacy of cabazitaxel in terms of non-progression at 6 weeks for the treatment of recurrent or metastatic head and neck cancer after failure of cisplatin, cetuximab and taxanes. Non-progression will be assessed after centralized review of CT-scans.
3 secondary outcomes
progression free survival
Time frame: 1-year
Toxicity according to NCI-CTCAE v4.0
Time frame: from the first dose up to 30 days after the last dose
Quality of life evaluated by the QLQ-C30 and H&N35 questionnaire
Time frame: at the inclusion, at 6 weeks and at the end of treatment
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 2 Mar 2021.
- Individual participant dataSharing planned: No. IPD will not be shared at an individual level, those data will be part of the study database including all enrolled patients.
Related trials for Recurrent Head and Neck Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cabazitaxel in people with Recurrent Head and Neck Cancer and Metastatic Head and Neck Cancer, run by UNICANCER at 5 sites in France.
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 12 inclusion and 19 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 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
non-progression at 6 weeks (time frame: 6 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 2 Mar 2021.