Recurrent DiseasePhase 2NCT00408252
Efficacy of SU 011248 in Head And Neck Carcinoma
A Phase 2 study testing biopsies and SU011248 in people with Recurrent Disease and Squamous Cell Head and Neck Carcinoma, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 9 sites in 2 countries.
Trial summary
Preclinical studies as well as phase I and II trials have demonstrated that SU11248 has antitumor activity in renal cell carcinoma, breast cancer, neuroendocrine tumor and GIST. So at the light of these pre-clinical and clinical data, it seems interesting and promising to test SU011248 in these poor prognosis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Disease, Squamous Cell Head and Neck Carcinoma, Palliative Treatment
- What is being tested?
- biopsies and SU011248
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Feb 2007to Dec 2011
- 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
- Recurrent and/or metastatic head and neck squamous cell carcinoma not amenable to curative treatment with surgery and/or chemotherapy and/or radiation
- Recurrence must be confirmed by anatomopathology (cytology or biopsy)
- At least one measurable lesion by MRI or CT-scan
- Failed or relapsing after first line chemotherapy including a platinum* or a taxane-based chemotherapy regimen
- Patients ineligible for chemotherapy could be included in first line
- ECOG performance status 0 -2, in stable medical condition
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- Patients must be able to swallow tablets
- Patients must have an expected survival of at least 3 months
- Paraffin-embedded tumor tissue available for immunohistochemistry
- Patients must be over 18 years old and must be able to give written informed consent
- Women of child-bearing age must have a negative pregnancy test
- Female patients of child-bearing age must use effective contraception until 3 months have elapsed after the last injection
- Patients must have normal organ function
- For patients with local recurrence and easily accessible tumors, acceptance of iterative biopsies to store tumor samples (Formaldehyde for immunochemistry, RNA later)
- Acceptance of giving 20 ml of blood for eventual pharmacogenomic analysis
- Acceptance of giving two plasma samples (3ml) at baseline and after 4 weeks of treatment with SU011248
- Signed informed consent prior to beginning protocol specific procedure
Who cannot join
- Non-squamous head and neck cancer
- Nasopharynx cancer
- Brain metastases
- More than two lines of chemotherapy for palliative treatment (except if chemotherapy was given as a part of a multimodal treatment given with a curative intent)
- Surgery or irradiation or investigational drugs within 4 weeks before study inclusion
- Other uncontrolled illnesses (active infections requiring antibiotics, bleeding disorders, …)
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- Active uncontrolled coronary disease or cardiac insufficiency (Ejection fraction below 40%)
- Previous malignancy, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
- Other concomitant anticancer therapies
- Previous treatment with anti-VEGF, PDGF, or kit therapies. EGFR therapy is not an exclusion criteria.
- Organic brain syndrome or significant psychiatric abnormality that would preclude participation in the full protocol and follow up.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
France6 sites
Centre Jean Perrin
Clermont-Ferrand, 263011
Centre G-f Leclerc
Dijon, 8021079
Centre Alexis Vautrin
Nancy, 4511
René Gauducheau
Saint-Herblain, 44805
CHU Bretonneau
Tours, 37044
Institut Gustave Roussy
Villejuif, 94805
Belgium3 sites
Cliniques Universiatires St LUC UCL
Brussels, 1200
clinique Sainte Elisabeth
Namur, 5000
Clinique universiataire de Mont Godinnes UCL
Yvoir, 5004
About this study
Official title: A Phase II Study Of Su011248 In Patients With Recurrent And/Or Metastatic Squamous Head And Neck Carcinoma.
Preclinical studies as well as phase I and II trials have demonstrated that SU11248 has antitumor activity in renal cell carcinoma, breast cancer, neuroendocrine tumor and GIST. So at the light of these pre-clinical and clinical data, it seems interesting and promising to test SU011248 in these poor prognosis patients.
Read the detailed description
This is an open-label phase II, multicenter study. Eligible patients will receive SU011248 in monotherapy (37.5 mg given continuously without interruption). Tumor check-up will be performed every 6-8 weeks. Treatment will be continued until disease progression or unacceptable toxicities according to the patient or the investigator (the median for treatment in renal cell study was 8 months).
Since, head and neck tumors are easily accessible for iterative biopsy, this study will offer the opportunity to get tumor biopsies before and after SU011248. Our study will allow translational research with biopsies at crucial timing: at baseline before any treatment, , during the treatment with SU011248 (cycle 1, between week 4 and 6), for patients with stable disease or partial response, a new biopsy will be performed at the time of disease progression to try to understand the mechanisms of tumor or resistance.
- Being tested
- biopsies, SU011248
- Keywords
- recurrent or locally advanced, cytokine failure
- Medical subject headings
- Recurrence, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsiesOther
No intervention, only biopsy for translational project
SU011248Drug
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | patients will receive SU011248 in monotherapy Receives: Other: biopsies; Drug: SU011248 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the efficacy of SU011248 alone in patients with head and neck cancer in term of overall response rate (RECIST, see statistical consideration)
Measured: every 6 weeks
Secondary outcomes (3)
Determine the safety profile of SU011248 alone in patients with head and neck cancer.
Measured: untill disaese progression
Determine the efficacy of SU011248 alone in patients with head and neck cancer: progression-free survival and survival.
Measured: untill disease progression
Translational research objective:To better understand the mechanisms of sunitinib resistance by the analysis of the tumor biopsies (RNA, gene expression profile) and protein profile (plasma samples). Exploratory analyses.
Measured: at week 6 and at disaese progression after recist response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2006 (estimated)
- Study startFeb 2007
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: Too frequent grade 3-4 toxicities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent DiseaseStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- 54 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Pascal H Machiels, MD PhD, Principal investigator, Cliniques Universitaires St Luc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408252
- Sponsor's protocol ID
- GORTEC 2006-01
- Other IDs
- IIR Study A6181004
- Status last verified
- Sep 2019
- First submitted
- 4 Dec 2006
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of Su011248 In Patients With Recurrent And/Or Metastatic Squamous Head And Neck Carcinoma.
- ClinicalTrials.gov ID
- NCT00408252
- Acronym / sponsor ID
- GORTEC 2006-01
- Keywords
- recurrent or locally advanced, cytokine failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too frequent grade 3-4 toxicities
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 6 Dec 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.
Preclinical studies as well as phase I and II trials have demonstrated that SU11248 has antitumor activity in renal cell carcinoma, breast cancer, neuroendocrine tumor and GIST. So at the light of these pre-clinical and clinical data, it seems interesting and promising to test SU011248 in these poor prognosis patients.
Detailed description
This is an open-label phase II, multicenter study. Eligible patients will receive SU011248 in monotherapy (37.5 mg given continuously without interruption). Tumor check-up will be performed every 6-8 weeks. Treatment will be continued until disease progression or unacceptable toxicities according to the patient or the investigator (the median for treatment in renal cell study was 8 months).
Since, head and neck tumors are easily accessible for iterative biopsy, this study will offer the opportunity to get tumor biopsies before and after SU011248. Our study will allow translational research with biopsies at crucial timing: at baseline before any treatment, , during the treatment with SU011248 (cycle 1, between week 4 and 6), for patients with stable disease or partial response, a new biopsy will be performed at the time of disease progression to try to understand the mechanisms of tumor or resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Other: biopsies, Drug: SU011248patients will receive SU011248 in monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Recurrent and/or metastatic head and neck squamous cell carcinoma not amenable to curative treatment with surgery and/or chemotherapy and/or radiation
- Recurrence must be confirmed by anatomopathology (cytology or biopsy)
- At least one measurable lesion by MRI or CT-scan
- Failed or relapsing after first line chemotherapy including a platinum* or a taxane-based chemotherapy regimen
- Patients ineligible for chemotherapy could be included in first line
Key exclusion criteria (11 listed)
- Non-squamous head and neck cancer
- Nasopharynx cancer
- Brain metastases
- More than two lines of chemotherapy for palliative treatment (except if chemotherapy was given as a part of a multimodal treatment given with a curative intent)
- Surgery or irradiation or investigational drugs within 4 weeks before study inclusion
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 |
|---|---|---|
| biopsiesNo intervention, only biopsy for translational project | Other | Arm A |
| SU011248no intervention | Drug | Arm A |
Primary outcome
Determine the efficacy of SU011248 alone in patients with head and neck cancer in term of overall response rate (RECIST, see statistical consideration)
Time frame: every 6 weeks
3 secondary outcomes
Determine the safety profile of SU011248 alone in patients with head and neck cancer.
Time frame: untill disaese progression
Determine the efficacy of SU011248 alone in patients with head and neck cancer: progression-free survival and survival.
Time frame: untill disease progression
Translational research objective:To better understand the mechanisms of sunitinib resistance by the analysis of the tumor biopsies (RNA, gene expression profile) and protein profile (plasma samples). Exploratory analyses.
Time frame: at week 6 and at disaese progression after recist response
Results and safety
The study was stopped early (reason given: Too frequent grade 3-4 toxicities). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
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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.
Jean-Pascal H Machiels, MD PhD principal investigator
Cliniques Universitaires St Luc
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing biopsies and SU011248 in people with Recurrent Disease and Squamous Cell Head and Neck Carcinoma, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 9 sites in 2 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 17 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: stopped early, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, Belgium. 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 stopped early (reason given: Too frequent grade 3-4 toxicities). Results are not available in the source record.
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?
Determine the efficacy of SU011248 alone in patients with head and neck cancer in term of overall response rate (RECIST, see statistical consideration) (time frame: every 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 19 Sep 2019.