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Efficacy of SU 011248 in Head And Neck Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00408252
Recruitment Status : Terminated (Too frequent grade 3-4 toxicities)
First Posted : December 6, 2006
Last Update Posted : April 20, 2018
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief 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.

Condition or disease Intervention/treatment Phase
Recurrent Disease Squamous Cell Head and Neck Carcinoma Palliative Treatment Other: biopsies Drug: SU011248 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Of Su011248 In Patients With Recurrent And/Or Metastatic Squamous Head And Neck Carcinoma.
Study Start Date : February 2007
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm A
patients will receive SU011248 in monotherapy
Other: biopsies
No intervention, only biopsy for translational project

Drug: SU011248
no intervention

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Determine the safety profile of SU011248 alone in patients with head and neck cancer. [ Time Frame: untill disaese progression ]
  2. Determine the efficacy of SU011248 alone in patients with head and neck cancer: progression-free survival and survival. [ Time Frame: untill disease progression ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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, …)
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00408252

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Cliniques Universiatires St LUC UCL
Bruxelles, Belgium, 1200
clinique Sainte Elisabeth
Namur, Belgium, 5000
Clinique universiataire de Mont Godinnes UCL
Yvoir, Belgium, 5004
Centre Jean Perrin
Clermont Ferrand, France, 263011
Centre G-f Leclerc
DIJON Cedex, France, 8021079
Centre Alexis Vautrin
Nancy, France, 4511
René Gauducheau
Saint Herblain Cedex, France, 44805
CHU Bretonneau
Tours cedex 1, France, 37044
Institut Gustave Roussy
Villejuif Cedex, France, 94805
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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Principal Investigator: Jean-Pascal H Machiels, MD PhD Cliniques Universitaires St Luc

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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain Identifier: NCT00408252     History of Changes
Other Study ID Numbers: GORTEC 2006-01
IIR Study A6181004
First Posted: December 6, 2006    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
recurrent or locally advanced
cytokine failure

Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action