Efficacy of SU 011248 in Head And Neck Carcinoma

NCT00408252 | Terminated Phase 2

• 2 other identifiers: GORTEC 2006-01IIR Study A6181004
• Study Type: interventional
• Target: 54
• Locations: 2 countries
• Sites: 9

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 these pre-clinical and clinical data, it seems interesting and promising to test SU011248 in these poor prognosis patients.

Conditions

Recurrent Disease; Squamous Cell Head and Neck Carcinoma; Palliative Treatment

Keywords

recurrent or locally advanced; cytokine failure

Outcome Measures

Primary Outcomes (1)

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

  every 6 weeks

Secondary Outcomes (3)

• Determine the safety profile of SU011248 alone in patients with head and neck cancer.

  untill disaese progression

• Determine the efficacy of SU011248 alone in patients with head and neck cancer: progression-free survival and survival.

  untill disease progression

• 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.

  at week 6 and at disaese progression after recist response

Study Arms (1)

Arm A

EXPERIMENTAL

patients will receive SU011248 in monotherapy

Other: biopsies; Drug: SU011248

Interventions

biopsies OTHER

No intervention, only biopsy for translational project

Arm A

SU011248 DRUG

no intervention

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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
• Organic brain syndrome or significant psychiatric abnormality that would preclude participation in the full protocol and follow up.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (9)

Cliniques Universiatires St LUC UCL

Brussels, 1200, Belgium

Location

clinique Sainte Elisabeth

Namur, 5000, Belgium

Location

Clinique universiataire de Mont Godinnes UCL

Yvoir, 5004, Belgium

Location

Centre Jean Perrin

Clermont-Ferrand, 263011, France

Location

Centre G-f Leclerc

Dijon, 8021079, France

Location

Centre Alexis Vautrin

Nancy, 4511, France

Location

René Gauducheau

Saint-Herblain, 44805, France

Location

CHU Bretonneau

Tours, 37044, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Recurrence; Squamous Cell Carcinoma of Head and Neck

Interventions

Biopsy; Sunitinib

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jean-Pascal H Machiels, MD PhD

  Cliniques Universitaires St Luc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2006
• First Posted: December 6, 2006
• Study Start: February 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 19, 2019

Record last verified: 2019-09

Locations

BE (3); FR (6)