drugset / Trial / NCT01256385
Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy
RandomizedParallel-groupOpen-labelTreatment
Summary
This phase II trial studies how well giving temsirolimus together with cetuximab works compared to temsirolimus alone in treating patients with recurrent and/or metastatic head and neck cancer who did not respond to previous therapy. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving temsirolimus together with cetuximab is more effective than giving temsirolimus alone.
Timeline
- Start
- 2010-11
- Primary completion
- 2013-12
- Completion
- 2013-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | — | Intravenous |
| Subject | Temsirolimus | Small molecule | — | Intravenous |
Indications
hypopharynx squamous cell carcinoma
larynx verrucous carcinoma
major salivary gland carcinoma
metastatic squamous cell carcinoma
nasal cavity and paranasal sinus squamous cell carcinoma
nasopharyngeal squamous cell carcinoma
oropharynx squamous cell carcinoma
salivary gland squamous cell carcinoma
tongue carcinoma
verrucous carcinoma of oral cavity