A phase I and randomised phase II study of Docetaxel and RAD001 (Everolimus) in advanced/recurrent or metastatic squamous cell carcinoma of the head and neck - DORA

• Conditions: ocally advanced or metastatic squamous cell carcinoma of the head and neck; MedDRA version: 9.1Level: LLTClassification code 10063569Term: Metastatic squamous cell carcinoma; MedDRA version: 9.1Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neck

• Registration Number: EUCTR2007-001951-20-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

-Histologically confirmed advanced/recurrent or metastatic squamous cell carcinoma of the head and neck
-Life expectancy >= 12 weeks
-ECOG 0 or 1
-Measurable disease (RECIST criteria)
-Age >= 18 years
-Written informed consent and able to attend for treatment and follow-up
-Adequate haematological, renal and liver function
-Patients may have received one line prior chemotherapy (not taxanes)
-Patients may have received prior radiotherapy (completed >= 6 months prior to recruitment)
-Negative pregnancy test (women of CBP) and willing to use approved contraception method (all patients)
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

-Potentially curable disease
-Disease relapsed within 6 months of radiotherapy
-Patients with locally advanced disease for whom radiotherapy is indicated
-Previous chemotherapy for any cancer, except for head and neck cancer
-Previous therapy with any erbB inhibitors (except Cetuximab given radiotherapy, as indicated in treatment algorithm)
-Treatment within the last 4 weeks with any investigational drug
-The current use of drugs which are known to inhibit CYP3A4 (except dexamethasone), or block P-glycoprotein including grapefruit juice
-Evidence of the presence of central nervous system metastases
-Evidence of uncontrolled infection
-Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
-History of hypersensitivity to docetaxel or any of its excipients
-Pregnant or breast-feeding

Study & Design

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