Clinical trial of temsirolimus in patients with squamous cell cancer of the head and neck
- Conditions
- 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: 14.0Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2009-014396-43-DE
- Lead Sponsor
- Medical School Hannover
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to determine the efficacy (progression free rate at day 84<br> [12 weeks]; PFR) of temsirolimus 25 mg i.v. once weekly in patients with relapsed or<br> recurrent HNSCC after failure of platinum- and cetuximab-based regimens.<br><br><br>;Secondary Objective: - Time to progression (TTP)<br>- The disease control rate (DCR: CR+PR+SD)<br>- The over all survival rate (OS)<br>- Safety and tolerability of temsirolimus (evaluating according to CTC 3.0 criteria)<br>- 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 Outcome Measures
Name Time Method Secondary end point(s): 1) time to progression<br>2) disease control rate<br>3) overall survival rate<br>4) safety and tolerablility of temsirolimus<br>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