A PHASE II STUDY OF SU011248 IN PATIENTS WITH RECURRENT AND/OR METASTATIC SQUAMOUS HEAD AND NECK CARCINOMA. - HNSCC SU protocol

• Conditions: Palliative patients with metastatic and/or recurrent head and neck cancer after failure of first line standard chemotherapy.; MedDRA version: 8.1Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neck

• Registration Number: EUCTR2006-001780-30-BE
• Lead Sponsor: Cliniques Universiatires St Luc- Centre du Cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-29
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Acceptance to participate to P-K sub-study (mandatory for part II)

1.Recurrent and/or metastatic head and neck squamous cell carcinoma not amenable to curative treatment with surgery and/or chemotherapy and/or radiation
2.Recurrence must be confirmed by anatomopathology (cytology or biopsy)
3.At least one measurable lesion by MRI or CT-scan
4.Failed or relapsing after first line chemotherapy including a platinum* or a taxane–based chemotherapy regimen
5.Patients ineligible for chemotherapy could be included in first line
6.ECOG performance status 0 -2, in stable medical condition
7.Patients must be able to swallow tablets
8.Patients must have an expected survival of at least 3 months
9.Paraffin-embedded tumor tissue available for immunohistochemistry
10.Patients must be over 18 years old and must be able to give written informed consent
11.Women of child-bearing age must have a negative pregnancy test
12.Female patients of child-bearing age must use effective contraception until 3 months have elapsed after the last injection
13.Patients must have normal organ function (Hemoglobin = 8 g/100 ml, Neutrophils = 1,500/mm3, Platelets = 100,000/mm3, Serum creatinine =1.5 mg/100 ml and or creatinine clearance > 60 ml/min, Serum bilirubin =2.0 mg/100 ml, Aminotransferases (AST/SGOT and ALT/SGPT) must be = 3x the upper institutional normal limit
14.For patients with local recurrence and easily accessible tumors, acceptance of iterative biopsies to store tumor samples (Formaldehyde for immunochemistry, RNA later)
15.Acceptance of giving 20 ml of blood for eventual pharmacogenomic analysis
16.Acceptance of giving two plasma samples (3ml) at baseline and after 4 weeks of treatment with SU011248
17.Signed informed consent prior to beginning protocol specific procedure

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Tumor located less than 5 mm from a major arterial vessel (The imaging will be reviewed before inclusion)

1.Non-squamous head and neck cancer
2.Nasopharynx cancer
3.Brain metastases
4.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)
5.Surgery or irradiation or investigational drugs within 4 weeks before study inclusion
6.Other uncontrolled illnesses (active infections requiring antibiotics, bleeding disorders, …)
7.Active uncontrolled coronary disease or cardiac insufficiency (Ejection fraction below 40%)
8.Previous malignancy, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
9.Other concomitant anticancer therapies
10.Previous treatment with anti-VEGF, PDGF, or kit therapies. EGFR therapy is not an exclusion criteria.
11.Organic brain syndrome or significant psychiatric abnormality that would preclude participation in the full protocol and follow up.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified