Dasatinib in Patients With Head and Neck Squamous Cell Carcinoma
· To determine the 12-week progression-free survival rate and the objective response rate as determined by RECIST criteria of patients with advanced, incurable head and neck cancer [head and neck squamous cell cancer (HNSCC)] treated with dasatinib.
- To define metabolic response rate using European Organization for Research and Treatment Center (EORTC) criteria for metabolic response by Positron emission tomography (PET) scan at 0, 8, and 12 weeks.
- To define overall survival time from initiation of dasatinib.
- To define duration of response
- To determine if there is a correlation between clinical benefit from dasatinib (defined as disease platelets), or changes in serum levels of cytokines, growth factors and growth factor receptors relevant to the Src signaling pathway.
- To examine the relationship between clinical benefit and EMS1 gene amplification and cortactin expression levels in tumor tissue prior to therapy (and if post-treatment biopsy available with the modulation of cortactin levels by treatment).
- To examine 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.
- To assess the tolerability of dasatinib in this patient population.
- To describe the PK profile and relative bioavailability of dasatinib suspension in patients receiving the drug through percutaneous feeding gastrostomy tube.
- To descriptively assess safety, toxicity and efficacy of dasatinib crushed and administered by feeding tube.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Dasatinib in the Treatment of 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)|
100 mg orally twice daily
100 mg By Mouth Twice Daily
The Study Drug:
Dasatinib is designed to block a protein that cancer may need to grow, survive, or spread.
If you are found to be eligible to take part in this study, you will take dasatinib by mouth twice a day, in 28-day (4-week) study "cycles." Tablets may be taken with or without food, but should be swallowed with at least 8 ounces of water. A light meal is not required, but may help you avoid getting a stomach ache when you take your dose. Tablets must be swallowed whole and may not be broken. If vomiting occurs within 30 minutes of swallowing the tablet(s), the dose may be replaced if the tablets can be seen and counted (in other words, if they are still whole and have not been digested). If you have difficulty swallowing the medication, you will be provided with instructions on how to prepare and take your study medication. You will be given a "pill diary" to write down when you take your medication, shown how to fill it out, and asked to bring the diary with you to each clinic visit.
You will have a study visit every 4 weeks (once a cycle) while you are receiving treatment. The following tests will be performed during each visit.
- Your complete medical history will be recorded.
- You will have a physical exam, including measurement of vital signs and weight.
- You will have blood drawn (about 2 teaspoons) for routine tests.
- You will have a performance status evaluation.
- Your study doctor will ask you about any medications you may be taking and your smoking history.
After the first 4 weeks of treatment and then every 2 cycles from then on, the disease status will be checked using a chest x-ray and either a computed tomography (CT) or magnetic resonance imaging (MRI) scan.
Length of Study:
You may continue receiving dasatinib for as long as you are benefitting. Your doctor may decide to take you off this study if you experience intolerable side effects or the disease gets worse.
This is an investigational study. Dasatinib is FDA approved and commercially available for the treatment of acute lymphoid and chronic myeloid leukemia.
However, its use in this research study is investigational.
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Vali Papadimitrakopoulou, MD||M.D. Anderson Cancer Center|