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Dasatinib in Patients With Head and Neck Squamous Cell Carcinoma
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, September 2008
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00507767
  Purpose

Primary Objective:

  • 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 treated with dasatinib.

Secondary Objectives:

  • To define metabolic response rate using European Organization for Research and Treatment Center (EORTC) criteria for metabolic response by 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 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.

Condition Intervention Phase
Head and Neck Cancer
Squamous Cell Carcinoma
Drug: Dasatinib
Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer
Drug Information available for: Dasatinib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase II Study of Dasatinib in the Treatment of Head and Neck Squamous Cell Carcinoma

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • The goal of this clinical research study is to learn if dasatinib can help to control HNSCC. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The safety of this drug will also be studied, as well as the drug's effect on different cells in the body. [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 35
Study Start Date: July 2007
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Dasatinib
Drug: Dasatinib
100 mg PO Twice Daily

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient has histologically proven squamous cell carcinoma of the head and neck that is recurrent after surgery and/or radiation therapy or chemoradiation therapy that was completed more than 6 months prior to study entry or is metastatic. and disease must be measurable by RECIST criteria.
  2. Patients must have measureable disease as defined by RECIST criteria.
  3. Patients have received </= 1 prior chemotherapeutic regimen for recurrent or metastatic disease
  4. Age >/= 18 years. Because dasatinib is currently being studied in a phase 1 pediatric trial (ADVL0516), eligibility for the current trial is restricted to adults.
  5. ECOG performance status 0-1
  6. Patients must have normal organ and marrow function as defined below: leukocytes >/= 3,000/mcL, absolute neutrophil count >/= 1,500/mcL, platelets >/= 100,000/mcL, Hgb >/= 9.0 g/dL, total bilirubin </= 1.5 X institutional upper limit of normal, albumin >/= 2.5 g/dL, AST(SGOT)/ALT(SGPT) </= 1.5 X institutional upper limit of normal, creatinine </= 3 mg/dl
  7. Paraffin embedded tumor tissue that is appropriate for IHC and FISH analysis must be available or patient must be amenable to biopsy to obtain tissue for the study.
  8. Ability to understand and the willingness to sign a written informed consent document.
  9. Patient must not be pregnant or breastfeeding. All sexually active females of child-bearing potential and all sexually active males with sexual partners of child-bearing potential should practice contraception (e.g. barrier, hormonal, IUD) or sexual abstinence while in the study and for two months following completion of therapy.
  10. Brain metastases permitted provided the patient does not require anticonvulsants or corticosteroids, or has been off them at least 7 days. Patients with brain metastases must be either > 4 weeks beyond cranial irradiation or must be felt not to require it at that time.
  11. The patient's O2 saturation must be >/= 92% on room air.

Exclusion Criteria:

  1. Chemotherapy or palliative radiotherapy for recurrent and/or metastatic disease within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or failure to recover to at least grade 1 from adverse events due to agents administered more than 4 weeks earlier.
  2. Other anti-neoplastic agents, i.e., cytotoxic chemotherapy, immunotherapy, radiotherapy or investigational therapy, used to treat the primary disease will not be allowed during the study. Local radiation (excluding radiotherapy to the target lesion) for supportive reasons involving a small radiation field may be allowed.
  3. Patient has a history of uncontrolled or severe medical disease which could compromise participation in the study such as uncontrolled diabetes (fasting blood glucose >200 mg/dl), uncontrolled hypertension (systolic BP>160 or diastolic BP>100 mm Hg), severe infection (bacterial infection requiring antibiotics or HIV), angina at rest, congestive heart failure NYHA class III or IV, ventricular arrhythmias requiring therapy, myocardial infarction within 6 months, (stated below), >grade 2 neuropathy.
  4. Patients may not be receiving any other investigational agents.
  5. Patients who require concurrent treatment with any medications or substances that are potent inhibitors or inducers of CYP3A4 are ineligible.
  6. Echocardiogram less than institutional normal measured by echocardiogram for subjects with history of congestive heart failure, symptoms of congestive heart failure, clinical evidence suggesting impaired cardiac function.
  7. Use of antithrombotic and/or anti-platelet agents (e.g., warfarin, heparin, low molecular weight heparin, and/or ibuprofen). Exception: Patients taking low dose aspirin.
  8. Patients may not have any clinically significant cardiovascular disease including the following: myocardial infarction or ventricular tachyarrhythmia within 6 months, prolonged QTc>480 msec (Fridericia correction), major conduction abnormality (unless a cardiac pacemaker is present).
  9. Pregnant women & women who are currently breast-feeding may not participate in this study. All women of childbearing potential must have a negative pregnancy test w/in 24 hours prior to enrolling in the study. All sexually active females of child-bearing potential & all sexually active males with sexual partners of child-bearing potential should practice contraception (e.g. barrier, hormonal, IUD) or sexual abstinence while in the study & for two months following completion of therapy. Postmenopausal women must be amenorrheic for at least 12 mths to be considered of non-childbearing potential.
  10. Patients having pleural effusion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507767

Contacts
Contact: Katherine Gillaspy, RN 713-792-6363

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Vali Papadimitrakopoulou, MD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Vali Papadimitrakopoulou, MD U.T.M.D. Anderson Cancer Center
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: U.T.M.D. Anderson Cancer Center ( Vali Papadimitrakopoulou, MD/Associate Professor )
Study ID Numbers: 2006-0571
Study First Received: July 26, 2007
Last Updated: September 25, 2008
ClinicalTrials.gov Identifier: NCT00507767  
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Head and Neck Cancer
Squamous Cell Carcinoma
Dasatinib
BMS-354825

Study placed in the following topic categories:
Epidermoid carcinoma
Dasatinib
Squamous cell carcinoma
Head and Neck Neoplasms
Carcinoma, squamous cell
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009