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Bortezomib and Docetaxel in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2008
Sponsors and Collaborators: Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00425750
  Purpose

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with docetaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bortezomib together with docetaxel works in treating patients with recurrent or metastatic head and neck cancer.


Condition Intervention Phase
Head and Neck Cancer
Drug: bortezomib
Drug: docetaxel
Procedure: laboratory biomarker analysis
Procedure: pharmacological study
Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer
Drug Information available for: Docetaxel Bortezomib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label
Official Title: Phase II Trial of Combination Weekly Bortezomib (VELCADE) and Docetaxel (TAXOTERE) in Patients With Recurrent and/ or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response data by RECIST criteria [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2005
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the overall response rate in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck treated with bortezomib and docetaxel.

Secondary

  • Determine the time to progression in patients treated with this regimen.
  • Determine the toxicity of this regimen.
  • Determine the duration of response in patients treated with this regimen.
  • Determine the overall survival and progression-free survival of these patients.
  • Determine 20S proteasome inhibition in peripheral blood mononuclear cells (PBMC) from these patients.
  • Determine the effect of bortezomib on NF-kB pathway in PBMC and serum samples.
  • Identify biomarkers of clinical response to bortezomib and docetaxel in PBMC and serum.
  • Determine quality of life, symptom burden, and physical function outcome in patients treated with this regimen.

OUTLINE: This is a prospective, open-label, nonrandomized study.

Patients receive docetaxel* IV over 30 minutes and bortezomib IV on days 1 and 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

NOTE: *Docetaxel is not administered on day 1 of course 1.

Blood samples are collected at baseline, after bortezomib administration on day 1 of course 1, and at the completion of treatment. The pharmacodynamics and pharmacogenomics of bortezomib are assessed in peripheral blood mononuclear cells (PBMC) and serum.

After completion of study treatment, patients are followed every 6 weeks for 1 year and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx

    • Recurrent or metastatic disease
  • Measurable disease
  • Not a candidate for curative therapy

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Absolute neutrophil count ≥ 1,500/mm³
  • Hemoglobin ≥ 8.0 g/dL
  • Platelet count ≥ 100,000/mm³
  • AST, ALT, and alkaline phosphatase (AP) meeting 1 of the following criteria:

    • AP normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)
    • AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN
    • AP ≤ 5 times ULN AND AST and ALT normal
  • Bilirubin normal
  • Creatinine clearance ≤ 2.0 mg/dL
  • No peripheral neuropathy ≥ grade 2 within the past 28 days
  • No myocardial infarction within the past 6 months
  • No New York Heart Association class III or IV heart failure
  • No uncontrolled angina
  • No severe uncontrolled ventricular arrhythmias
  • No electrocardiographic evidence of acute ischemia or active conduction system abnormalities
  • No known hypersensitivity to bortezomib, boron, or mannitol
  • No known severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
  • No serious medical or psychiatric illness that would preclude study participation
  • No other malignancy within the past 3 years except for early-stage nonmelanomatous skin cancer, carcinoma in situ of the cervix, or early-stage prostate cancer
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy for recurrent or metastatic disease
  • At least 28 days since prior and no other concurrent investigational drugs
  • No other concurrent anticancer therapy
  • No other concurrent chemotherapy
  • No concurrent complementary or herbal medicine
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00425750

Locations
United States, Kentucky
Jennie Stuart Medical Center Recruiting
Hopkinsville, Kentucky, United States, 42240-2400
Contact: Ratilal G. Gajera, MD     270-887-0100        
Purchase Cancer Group - Paducah Recruiting
Paducah, Kentucky, United States, 42001
Contact: Kristy Harris, RN     270-554-6556        
United States, Tennessee
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee Recruiting
Knoxville, Tennessee, United States, 37901
Contact: Clinical Trials Office - Baptist Regional Cancer Center     865-632-5717        
West Tennessee Cancer Center at Jackson-Madison County General Hospital Recruiting
Jackson, Tennessee, United States, 38301
Contact: Clinical Trials Office - West Tennessee Cancer Center     731-425-6865        
Tennessee Plateau Oncology - Crossville Recruiting
Crossville, Tennessee, United States, 38555
Contact: Dirk C. Davidson, MD     931-484-9511        
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center     800-811-8480        
MBCCOP - Meharry Medical College - Nashville Recruiting
Nashville, Tennessee, United States, 37208-3599
Contact: Chukwuemeka Ikpeazu, MD, PhD     615-327-5864     eikpeazu@mmc.edu    
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Study Chair: Christine Chung, MD Vanderbilt-Ingram Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: Vanderbilt-Ingram Cancer Center ( Christine Chung )
Study ID Numbers: CDR0000525999, VU-VICC-HN-0501, MILLENIUM-X05170, VU-VICC-IRB-050183
Study First Received: January 19, 2007
Last Updated: October 22, 2008
ClinicalTrials.gov Identifier: NCT00425750  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IV squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the larynx

Study placed in the following topic categories:
Squamous cell carcinoma
Bortezomib
Recurrence
Carcinoma
Epidermoid carcinoma
Docetaxel
Head and Neck Neoplasms
Carcinoma, squamous cell
Laryngeal carcinoma
Hypopharyngeal cancer
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Carcinoma, squamous cell of head and neck
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009