Tongue Cancer Clinical Trial
Official title:
A Phase 2 Study of Dasatinib in Head and Neck Squamous Cell Carcinoma
This phase II trial studies how well dasatinib works in treating patients with head and neck cancer that has come back or spread to other areas of the body. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To determine the 12-week progression-free survival rate and the objective response rate,
as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, in patients
with recurrent or metastatic squamous cell carcinoma of the head and neck treated with
dasatinib.
SECONDARY OBJECTIVES:
I. To define metabolic response rate by positron emission tomography (PET) scan at 0, 8, and
12 weeks.
II. To define overall survival distribution from initiation of dasatinib. III. To define
duration of response. IV. To determine if there is a correlation between clinical benefit
from dasatinib (defined as disease response or stabilization) and pharmacokinetics,
pharmacodynamics (phosphorylated Src [pSrc] expression in platelets), or changes in serum
levels of cytokines, growth factors, and growth factor receptors relevant to the Src
signaling pathway.
V. To examine the relationship between clinical benefit and mammary tumor and squamous cell
carcinoma-associated protein (EMS1) gene amplification and cortactin expression levels in
tumor tissue prior to therapy and the modulation of cortactin levels by treatment.
VI. To compare the effects of dasatinib on apoptosis by terminal deoxynucleotidyl
transferase dUTP nick end labeling (TUNEL) assay in tumor tissues comparing pre- and
post-treatment biopsies.
VII. To assess the tolerability of dasatinib in this patient population. VIII. To describe
the pharmacokinetic (PK) profile and relative bioavailability of dasatinib suspension in
patients receiving the drug through percutaneous gastrostomy tube.
IX. To descriptively assess safety, toxicity, and efficacy of dasatinib crushed and
administered by feeding tube.
OUTLINE:
Patients receive dasatinib orally (PO) or via percutaneous gastrostomy (PEG) tube twice
daily (BID). Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up for at least 4 weeks.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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