Efficacy of SU 011248 in Head And Neck Carcinoma

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status and phase

Terminated

Phase 2

Conditions

Recurrent Disease

Palliative Treatment

Squamous Cell Head and Neck Carcinoma

Treatments

Other: biopsies

Drug: SU011248

Study type

Interventional

Funder types

Other

Identifiers

NCT00408252

GORTEC 2006-01

IIR Study A6181004

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.