Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00425750
Status:
COMPLETED
Last Update Posted:
2011-11-16
First Post:
2007-01-19
Brief Title:
Bortezomib and Docetaxel in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Vanderbilt-Ingram Cancer Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
Primary
Determine the overall response rate in patients with recurrent andor 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
Primary
Determine the overall response rate in patients with recurrent andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VU-VICC-IRB-050183 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA068485 |
| P30CA068485 | NIH | None | None |
| VU-VICC-HN-0501 | None | None | None |
| MILLENIUM-X05170 | None | None | None |