Patients with metastatic or local recurrenct squamous carcinoma of the head and neck (HNSCC) who have measurable progressive disease after platinum-based radiochemotherapy or recurrence or metastatic progressive disease after first line platinum-based chemotherapy. Failure of at least one line of cisplatin-based therapy and cetuximab is required. MedDRA version: 14.0 Level: LLT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms b
Conditions
Sponsors
Medical School Hannover
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed written informed consent must be given prior to study inclusion - Histological or cytological confirmed recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC) - Measurable progressive disease after platinum-based radiochemotherapy or recurrence or metastatic progressive disease after first line platinum-based chemotherapy - Patients with loco-regional recurrence need to be progression free for at least 6 months after platinum-based radiochemotherapy, if locoregional recurrence is the only lesion - Cetuximab must have been included in at least one prior line of therapy - Prior exposure to a taxane is permitted - Disease is not amenable to surgery, radiotherapy or platinum-based chemotherapy - At least one measurable lesion according to RECIST (version 1.0) criteria - Age > 18 years - ECOG performance status 0-2 - Brain metastases require completion of local therapy with discontinuation of steroids prior to start of teatment 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Live expectancy less than 3 months - Anticancer treatment during the last 30 days prior to start of treatment including systemic therapy, radiotherapy or major surgery - Participation in a clinical trial within the last 30 days prior to study treatment - Serious illness or medical condition other than the disease under study - Other malignancies within 3 years, with exception of HNSCC, history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix - Inability to potentially complete follow up and treatment per protocol for psychological, familial, sociological or geographical reasons - Pregnancy or breast feeding - Known allergic/ hypersensitivity reaction to any component of the treatment - Concurrent treatment with oral anticoagulants - Uncontrolled diabetes: fasting serum glucose > 2.0 ULN - Active or uncontrolled infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine the efficacy (progression free rate at day 84 [12 weeks]; PFR) of temsirolimus 25 mg i.v. once weekly in patients with relapsed or recurrent HNSCC after failure of platinum- and cetuximab-based regimens. ;Secondary Objective: - Time to progression (TTP) - The disease control rate (DCR: CR+PR+SD) - The over all survival rate (OS) - Safety and tolerability of temsirolimus (evaluating according to CTC 3.0 criteria) - Evaluation of predictive markers of tumor response in serum and tumor specimen;Primary end point(s): - progressive free rate (PFR) at treatment day 84 (12 weeks);Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) time to progression 2) disease control rate 3) overall survival rate 4) safety and tolerablility of temsirolimus 5) evaluation of predictive markers of tumor response in serum and tumor specimen;Timepoint(s) of evaluation of this end point: 1) - 5) until end of follow-up period | — |
Countries
Germany
Contacts
Public ContactDr. med. Viktor Grünwald
Hannover Medical School
Outcome results
None listed