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Efficacy of SU 011248 in Head And Neck Carcinoma

Primary Purpose

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

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
biopsies
SU011248
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Disease focused on measuring recurrent or locally advanced, cytokine failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cliniques Universiatires St LUC UCL
  • clinique Sainte Elisabeth
  • Clinique universiataire de Mont Godinnes UCL
  • Centre Jean Perrin
  • Centre G-f Leclerc
  • Centre Alexis Vautrin
  • René Gauducheau
  • CHU Bretonneau
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm A

Arm Description

patients will receive SU011248 in monotherapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 4, 2006
Last Updated
September 18, 2019
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT00408252
Brief Title
Efficacy of SU 011248 in Head And Neck Carcinoma
Official Title
A Phase II Study Of Su011248 In Patients With Recurrent And/Or Metastatic Squamous Head And Neck Carcinoma.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Too frequent grade 3-4 toxicities
Study Start Date
February 2007 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Disease, Squamous Cell Head and Neck Carcinoma, Palliative Treatment
Keywords
recurrent or locally advanced, cytokine failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
patients will receive SU011248 in monotherapy
Intervention Type
Other
Intervention Name(s)
biopsies
Intervention Description
No intervention, only biopsy for translational project
Intervention Type
Drug
Intervention Name(s)
SU011248
Intervention Description
no intervention
Primary Outcome Measure Information:
Title
Determine the efficacy of SU011248 alone in patients with head and neck cancer in term of overall response rate (RECIST, see statistical consideration)
Time Frame
every 6 weeks
Secondary Outcome Measure Information:
Title
Determine the safety profile of SU011248 alone in patients with head and neck cancer.
Time Frame
untill disaese progression
Title
Determine the efficacy of SU011248 alone in patients with head and neck cancer: progression-free survival and survival.
Time Frame
untill disease progression
Title
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.
Time Frame
at week 6 and at disaese progression after recist response

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Pascal H Machiels, MD PhD
Organizational Affiliation
Cliniques Universitaires St Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques Universiatires St LUC UCL
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
clinique Sainte Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Clinique universiataire de Mont Godinnes UCL
City
Yvoir
ZIP/Postal Code
5004
Country
Belgium
Facility Name
Centre Jean Perrin
City
Clermont Ferrand
ZIP/Postal Code
263011
Country
France
Facility Name
Centre G-f Leclerc
City
DIJON Cedex
ZIP/Postal Code
8021079
Country
France
Facility Name
Centre Alexis Vautrin
City
Nancy
ZIP/Postal Code
4511
Country
France
Facility Name
René Gauducheau
City
Saint Herblain Cedex
ZIP/Postal Code
44805
Country
France
Facility Name
CHU Bretonneau
City
Tours cedex 1
ZIP/Postal Code
37044
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

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Efficacy of SU 011248 in Head And Neck Carcinoma

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