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A Phase II Study Of Su011248 In Patients With Recurrent And/Or Metastatic Squamous Head And Neck Carcinoma.

Phase 2
18 Years
Not Enrolling
Recurrent Disease, Squamous Cell Head and Neck Carcinoma, Palliative Treatment

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Trial Information

A Phase II Study Of Su011248 In Patients With Recurrent And/Or Metastatic Squamous Head And Neck Carcinoma.

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.

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the efficacy of SU011248 alone in patients with head and neck cancer in term of overall response rate (RECIST, see statistical consideration)

Outcome Time Frame:

every 6 weeks

Safety Issue:


Principal Investigator

Jean-Pascal H Machiels, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cliniques Universitaires St Luc


Belgium: Ministry of Social Affairs, Public Health and the Environment

Study ID:

GORTEC 2006-01



Start Date:

February 2007

Completion Date:

December 2011

Related Keywords:

  • Recurrent Disease
  • Squamous Cell Head and Neck Carcinoma
  • Palliative Treatment
  • recurrent or locally advanced
  • cytokine failure
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms