Dasatinib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well dasatinib works in treating patients with recurrent or metastatic head and neck cancer.
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
Recurrent Metastatic Squamous Neck Cancer With Occult Primary
Recurrent Salivary Gland Cancer
Recurrent Squamous Cell Carcinoma of the Hypopharynx
Recurrent Squamous Cell Carcinoma of the Larynx
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
Recurrent Squamous Cell Carcinoma of the Nasopharynx
Recurrent Squamous Cell Carcinoma of the Oropharynx
Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Recurrent Verrucous Carcinoma of the Larynx
Recurrent Verrucous Carcinoma of the Oral Cavity
Salivary Gland Squamous Cell Carcinoma
Stage IV Salivary Gland Cancer
Stage IV Squamous Cell Carcinoma of the Hypopharynx
Stage IV Squamous Cell Carcinoma of the Larynx
Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IV Squamous Cell Carcinoma of the Nasopharynx
Stage IV Squamous Cell Carcinoma of the Oropharynx
Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Stage IV Verrucous Carcinoma of the Larynx
Stage IV Verrucous Carcinoma of the Oral Cavity
Untreated Metastatic Squamous Neck Cancer With Occult Primary
Procedure: laboratory biomarker analysis
Procedure: pharmacological study
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Dasatinib in Head and Neck Squamous Cell Carcinoma|
- Number of Participants With Progression-free Survival at 12-weeks [ Time Frame: At 12-weeks ] [ Designated as safety issue: No ]Progression-free survival (PFS) is defined as stable disease or better. Participants who have received at least one dose of dasatinib and who die or leave the study before 12 weeks will be counted as having progressive disease.
|Study Start Date:||July 2007|
|Study Completion Date:||February 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Experimental: Treatment (dasatinib)
Dasatinib 100 mg orally or by percutaneous gastrostomy tube twice daily on days 1-28.
100 mg given orally (PO) or by percutaneous gastrostomy tube twice a day, 28-day cycles.Procedure: laboratory biomarker analysis
Correlative studyProcedure: pharmacological study
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.
I. To define metabolic response rate by positron emissions test (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 (PK), pharmacodynamics (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 EMS1 gene amplification and cortactin expression levels in tumor tissue prior to therapy and the modulation of cortactin levels by treatment (if post-treatment biopsy available).
VI. To compare the effects of dasatinib on apoptosis by terminal deoxynucleotidyl transferase-mediated dUTP-biotin nick end labeling (TUNEL) assay using pre- vs post-treatment tumor tissue biopsy samples.
VII. To assess the tolerability of dasatinib in this patient population.
VIII. To describe the 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 or by percutaneous gastrostomy tube twice daily on days 1-28.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected periodically for pharmacokinetic, pharmacodynamic, and biomarker correlative studies. Techniques used include Liquid chromatography-mass spectrometry (LC-MS) assay, enzyme-linked immunosorbant assay (ELISA), and protein multiplex immunoassay. Paraffin-embedded tumor tissue samples are analyzed for EMS1 gene amplification and cortactin expression levels by Fluorescence in situ hybridization (FISH) and Immunohistochemistry (IHC) and apoptosis by TUNEL assay.
After completion of study treatment, patients are followed for at least 4 weeks.
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Vassiliki Papadimitrakopoulou, MD||UT MD Anderson Cancer Center|