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

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 120

Inclusion Criteria

1. Locally advanced or metastatic squamous cell carcinoma of the head and neck (histologically proven)
2. Estimated life expectancy of at least 12 weeks
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. Measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST) criteria (NB: For the purposes of this study recurrent disease within a previous radiation field can be considered to be measurable)
5. Aged 18 years or over
6. Patient willing and able to give written informed consent
7. Haematological parameters within a week prior to study entry: -
7.1. Blood cell counts:
a. Absolute neutrophils greater than or equal to 1.5 x 10^9/L
b. Platelets greater than or equal to 100 x 10^9/L
c. Haemoglobin greater than or equal to 10 g/dl
7.2. Renal function:
a. Urea and creatinine within normal limits
7.3. Hepatic functions:
a. Serum bilirubin within normal limits
b. AST or ALT <1.5 x ULN with alkaline phosphatase <2.5 x ULN
8. Patients may have received one line of prior chemotherapy for locally advanced or metastatic disease (but not a taxane)
9. Patients may have received prior radiation therapy for locally advanced or metastatic disease (but must have completed the radiotherapy more than six months before recruitment)
10. Female patients potentially able to child bear should have a negative pregnancy test prior to commencing the study drugs, and agree to use an approved contraceptive method (Intrauterine Device [IUD], birth control pills or barrier device) during and for 3 months after the last dose of the study drugs. All male patients should take adequate contraceptive precautions during and up to 2 months after the last dose of the study drugs

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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