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Imatinib Mesylate (Gleevec) and Docetaxel in Patients With Head and Neck Squamous Cell Cancer
This study is ongoing, but not recruiting participants.
First Received: June 12, 2007   Last Updated: January 8, 2009   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: Novartis
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00485485
  Purpose

Primary Objective:

  • To determine the efficacy of the combination of imatinib mesylate and docetaxel in recurrent or metastatic head and neck squamous cell cancer by serial measurements of tumor response (extent, frequency, duration).

Secondary Objectives:

  • To assess the safety and tolerability of imatinib mesylate and docetaxel in patients with recurrent or metastatic head and neck squamous cell cancer.
  • To explore the biologic effects of imatinib mesylate and docetaxel on tumor tissue by immunohistochemical analysis of microvessel density and phosphorylation of PDGF-R.
  • To explore the effects of imatinib mesylate and docetaxel on surrogate markers in serum.
  • To assess the rate of survival.

Condition Intervention Phase
Head and Neck Cancer
Squamous Cell Cancer
Drug: Imatinib Mesylate
Drug: Docetaxel
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase II Study of Imatinib Mesylate and Docetaxel in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To learn if Gleevec® (imatinib mesylate) given with Taxotere® (docetaxel) can help to control head and neck squamous cell cancer that has spread or reappeared. [ Time Frame: 29 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 58
Study Start Date: January 2007
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Imatinib Mesylate + Docetaxel
Drug: Imatinib Mesylate
400 mg PO Daily
Drug: Docetaxel
60 mg/m^2 IV Over 1 Hour Every 3 Weeks

  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. A written, voluntary informed consent form must be completed prior to beginning any study procedure.
  2. Patients >/= 18 years of age.
  3. Histologically documented diagnosis of head and neck squamous cell cancer
  4. At least one measurable site of disease and can be assessed by RECIST.
  5. Performance status 0-2 (ECOG)
  6. Patients must have adequate hepatic, renal, and bone marrow function, defined as the following: (1) total bilirubin < 1.5 x ULN; (2) SGOT and SGPT < 2.5 x UNL; (3) creatinine < 1.5 x ULN; (4) ANC > 1.5 x 10^9/L; (5) platelets > 100 x 10^9/L.
  7. Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control (i.e. condoms, diaphragm) throughout the study and for up to 3 months following discontinuation of study drug.
  8. Patients who have not been treated for recurrent or metastatic HNSCC (i.e. Patients who have been treated with chemotherapy for induction/adjuvant or concurrent therapy with radiation in the setting of definitive treatment but have now developed recurrent or metastatic disease are eligible).

Exclusion Criteria:

  1. Prior exposure to docetaxel or imatinib mesylate.
  2. Patient has received any other investigational agents within 30 days of first day of study drug dosing.
  3. Patients with myocardial infarction within the past 6 months or New York Heart Association class 3 or 4 congestive heart failure.
  4. Female patients who are pregnant or breast-feeding.
  5. Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection (i.e. septic).
  6. Patient has unstable brain metastasis. Unstable brain metastasis is defined as patients on steroid medication to control symptoms or patient with motor neurologic compromise due to brain metastasis. Patients with treated brain metastasis are eligible if they are > 6 weeks out from therapy and off all steroid medication.
  7. Patient has known chronic liver disease (i.e., chronic active hepatitis or cirrhosis).
  8. Patient has a known diagnosis of human immunodeficiency virus (HIV) infection. HIV patients are at much greater risk of infection when receiving highly myelosuppressive agents (docetaxel and imatinib) and for safety reasons are not eligible for this trial.
  9. Patient received chemotherapy within 4 weeks (6 weeks for nitrosourea or mitomycin-C) prior to study entry, unless the disease is rapidly progressing.
  10. Patient previously received radiotherapy to >/= 25 % of the bone marrow
  11. Patient had a major surgery within 2 weeks prior to study entry.
  12. Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
  13. Patients must agree not to use herbal remedies or other over-the-counter biologics (i.e. shark cartilage)
  14. History of hypersensitivity to docetaxel or other taxane therapy.
  15. History of severe hypersensitivity reaction to drugs formulated with polysorbate 80.
  16. Patients taking therapeutic levels of warfarin. However, patients receiving 1 mg daily for catheter related anticoagulation are eligible for the study.
  17. Prior pericardial effusion requiring intervention such as pericardiocentesis or pericardial window within 2 months of study entry.
  18. Patient is < 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed.
  19. Patients with a history of Regional Ileitis, Colitis, or Crohn's disease, or any other relevant medical history related to the integrity of the bowel wall as there may be an increased risk of bowel perforation with the combination of Docetaxel and Imatinib.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00485485

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Novartis
Investigators
Principal Investigator: Anne S. Tsao, MD U.T.M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: U.T.M.D. Anderson Cancer Center ( Anne S. Tsao, MD/Assistant Professor )
Study ID Numbers: 2006-0362
Study First Received: June 12, 2007
Last Updated: January 8, 2009
ClinicalTrials.gov Identifier: NCT00485485     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Head and Neck Cancer
Squamous Cell Cancer
Imatinib Mesylate
Gleevec
Imatinib
STI571
Docetaxel
Taxotere

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Carcinoma
Docetaxel
Imatinib
Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Therapeutic Uses
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009