Efficacy of SU 011248 in Head And Neck Carcinoma - Full Text View

Sponsored by:	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Information provided by:	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:	NCT00408252

Purpose

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	Intervention	Phase
Recurrent Disease Squamous Cell Head and Neck Carcinoma Palliative Treatment	Other: biopsies Drug: SU011248	Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Sunitinib malate Sunitinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study Of Su011248 In Patients With Recurrent And/Or Metastatic Squamous Head And Neck Carcinoma.

Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Determine the safety profile of SU011248 alone in patients with head and neck cancer. [ Time Frame: untill disaese progression ] [ Designated as safety issue: Yes ]
Determine the efficacy of SU011248 alone in patients with head and neck cancer: progression-free survival and survival. [ Time Frame: untill disease progression ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	38
Study Start Date:	February 2007
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Intervention Details:

No intervention, only biopsy for translational project

no intervention

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408252

Locations

Belgium
Cliniques Universiatires St LUC UCL
Bruxelles, Belgium, 1200
clinique Sainte Elisabeth
Namur, Belgium, 5000
Clinique universiataire de Mont Godinnes UCL
Yvoir, Belgium, 5004
France
Institut Gustave Roussy
Villejuif Cedex, France, 94805
Centre G-f Leclerc
DIJON Cedex, France, 8021079
Centre Alexis Vautrin
Nancy, France, 4511
René Gauducheau
Saint Herblain Cedex, France, 44805
Centre Jean Perrin
Clermont Ferrand, France, 263011
CHU Bretonneau
Tours cedex 1, France, 37044

Sponsors and Collaborators

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

Principal Investigator:

Jean-Pascal H Machiels, MD PhD

Cliniques Universitaires St Luc

More Information

No publications provided

Responsible Party:	Cliniques Universitaires Sain-Luc ( Professor Machiels )
Study ID Numbers:	GORTEC 2006-01, IIR Study A6181004
Study First Received:	December 4, 2006
Last Updated:	March 27, 2009
ClinicalTrials.gov Identifier:	NCT00408252 History of Changes
Health Authority:	Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

recurrent or locally advanced
cytokine failure

Study placed in the following topic categories:

Sunitinib
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Angiogenesis Inhibitors

Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Disease Attributes
Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Angiogenesis Inhibitors
Recurrence
Pharmacologic Actions
Carcinoma

Neoplasms
Pathologic Processes
Sunitinib
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009