Phase Ib Study of Erlotinib Prior to Surgery in Patients With Head and Neck Cancer (NCT00954226) | Clinical Trial Compass
CompletedPhase 1
Phase Ib Study of Erlotinib Prior to Surgery in Patients With Head and Neck Cancer
United States48 participantsStarted 2009-08-05
Plain-language summary
This randomized phase Ib trial studies standard-dose or high-dose erlotinib hydrochloride before surgery in treating patients with head and neck cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with histologically confirmed cancer of the head and neck. Patients with salivary gland tumors and squamous cell carcinomas of the skin are also eligible. (Note: Any patient with a diagnosis of aggressive squamous cell carcinoma of the skin and determined to be surgically resectable will be considered for eligibility. These patients are typically seen in the Head \& Neck surgery clinic and decisions for study consideration will be based on consultations with the department of Head \& Neck surgery.)
* The patient must have biopsy-accessible disease.
* Patients must be surgical candidates (either definitive or palliative setting).
* Patients may have received prior therapy including cytotoxic chemotherapy (e.g. platinum drugs and taxanes) and radiation therapy.
* Patients must have a performance score (ECOG) of 0-2.
* Patients should have adequate bone marrow function, as defined by peripheral granulocyte count of \>/= 1,000/mm³, and a platelet count of \>/= 50,000/mm³.Patients must have adequate liver function with a bilirubin \</= 1.5 times the upper limit of normal (ULN). Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be \</= 2 x the ULN and alkaline phosphatase must be \</= 2 x ULN.
* Patients should have adequate renal function (serum creatinine \</= 1.5 x ULN).
* Age \>/= 18 years
* Ability to understand and the willingness to sign a written informed consent document indicating that they are aware of the investigat…
What they're measuring
1
Change in modulation of the biomarker phospho-Akt in tumor specimens