Status:
TERMINATED
Efficacy of SU 011248 in Head And Neck Carcinoma
Lead Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Conditions:
Recurrent Disease
Squamous Cell Head and Neck Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00408252
Start Date
February 1 2007
End Date
December 1 2011
Last Update
September 19 2019
Active Locations (9)
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1
Cliniques Universiatires St LUC UCL
Brussels, Belgium, 1200
2
clinique Sainte Elisabeth
Namur, Belgium, 5000
3
Clinique universiataire de Mont Godinnes UCL
Yvoir, Belgium, 5004
4
Centre Jean Perrin
Clermont-Ferrand, France, 263011