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Sponsors and Collaborators: |
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00425750 |
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 |
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Head and Neck Cancer |
Drug: bortezomib Drug: docetaxel Procedure: laboratory biomarker analysis Procedure: pharmacological study |
Phase II |
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) |
Estimated Enrollment: | 50 |
Study Start Date: | August 2005 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
PATIENT CHARACTERISTICS:
AST, ALT, and alkaline phosphatase (AP) meeting 1 of the following criteria:
PRIOR CONCURRENT THERAPY:
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 |
Study Chair: | Christine Chung, MD | Vanderbilt-Ingram Cancer Center |
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 |
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 |
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 |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |