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)
- 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.
- 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
- 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.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Patient Response to Treatment
Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
7.55 months (average duration, on study to off study)
Barbara Murphy, MD
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VICC HN 0501
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|MBCCOP - Meharry Medical College - Nashville||Nashville, Tennessee 37208-3599|
|West Tennessee Cancer Center at Jackson-Madison County General Hospital||Jackson, Tennessee 38301|
|Jennie Stuart Medical Center||Hopkinsville, Kentucky 42240|
|Purchase Cancer Group - Paducah||Paducah, Kentucky 42001|
|Tennessee Plateau Oncology - Crossville||Crossville, Tennessee 38555|
|Baptist Regional Cancer Center at Baptist Riverside||Knoxville, Tennessee 37901|