Clinical Trials Directory

Trials / Completed

CompletedNCT01256385

Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy

A T1 Translational Multicenter Randomized Phase II Study of Temsirolimus Versus Cetuximab Plus Temsirolimus in Patients With Recurrent / Metastatic Head and Neck Cancer, Who Failed Prior EGFR Based Therapy

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
86 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Primary endpoint is progression free survival (PFS) of cetuximab/temsirolimus combination cohort (Arm A) compared to temsirolimus alone (Arm B). SECONDARY OBJECTIVES: I. Progression-free survival (PFS) of cetuximab/temsirolimus combination group (Arm A) and temsirolimus control group (Arm B) compared to a historic control cohort. II. Subgroup analysis of myofibroblast (+) cohort (PFS). III. Overall survival (OS). IV. Toxicities. V. Response (Response Evaluation Criteria in Solid Tumors \[RECIST\])/absolute tumor shrinkage (waterfall plot analysis). VI. Activity of combination therapy (temsirolimus/cetuximab) after failure (progressive disease \[PD\]) of temsirolimus monotherapy. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive temsirolimus intravenously (IV) over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A. After completion of study therapy, patients are followed up for a minimum of 8 weeks and then once a year for 5 years.

Conditions

Interventions

TypeNameDescription
BIOLOGICALCetuximabGiven IV
OTHERLaboratory Biomarker AnalysisCorrelative studies
DRUGTemsirolimusGiven IV

Timeline

Start date
2010-11-01
Primary completion
2013-12-01
Completion
2013-12-01
First posted
2010-12-08
Last updated
2017-03-27
Results posted
2017-02-06

Locations

24 sites across 2 countries: United States, China

Source: ClinicalTrials.gov record NCT01256385. Inclusion in this directory is not an endorsement.