A phase II study of CP-751,871 in patients with recurrent and/or metastatic squamous head and neck carcinoma - IGF-1R protocol
- Conditions
- Palliative patients with recurrent and/or metastatic head and neck cancer after failure of first line standard chemotherapy.MedDRA version: 9.1Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IV
- Registration Number
- EUCTR2008-004707-59-BE
- Lead Sponsor
- Cliniques Universitaires Saint Luc-Centre du Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 37
-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 have an expected survival of at least 3 months
-paraffin-embedded tumor tissue available for immunohistochemistery
-patients must be over 18 years old and must be able to give written inform consent.
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
-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 investigationnal drugs within 4 weeks before study inclusion
-prior anti-IGF-1R therapy
-other concomitant anti cancer therapy
-other uncontrolled illnesses
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method