Bortezomib and Docetaxel in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00425750|
Recruitment Status : Completed
First Posted : January 23, 2007
Results First Posted : April 4, 2011
Last Update Posted : November 16, 2011
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 or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: bortezomib Drug: docetaxel Other: laboratory biomarker analysis Other: pharmacological study||Phase 2|
- 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 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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)|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
U.S. FDA Resources
Docetaxel (40 mg/m2) IV Infusion over 30 minutes every 3 weeks (Day 1 and 8 of 21 day cycle)except the first dose is held on Day 1 of Cycle 1.
Bortezomib (1.6mg/m2) IV 3-5 second push every 3 weeks (Day 1 and 8 of 21 day cycle).Bortezomib is given as a single agent only on Day 1 of Cycle 1.
1.6 mg/m2 through a vein on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.Drug: docetaxel
40 mg/m2 through a vein on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1.Other: laboratory biomarker analysis
Tissue and blood collection.Other: pharmacological study
- Patient Response to Treatment [ Time Frame: 7.55 months (average duration, on study to off study) ]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.
- Overall Survival [ Time Frame: 7.55 months (average duration, on study to off study) ]Median survival time of patients, calculated as on-study date to date of death or off-study date (censored)
- Progression-free Survival [ Time Frame: 7.55 months (average duration, on study to off study) ]Median duration of survival without disease progression, calculated as on-study date to date of progression or date of death (censored) or off-study date (censored)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00425750
|United States, Kentucky|
|Jennie Stuart Medical Center|
|Hopkinsville, Kentucky, United States, 42240-2400|
|Purchase Cancer Group - Paducah|
|Paducah, Kentucky, United States, 42001|
|United States, Tennessee|
|Tennessee Plateau Oncology - Crossville|
|Crossville, Tennessee, United States, 38555|
|West Tennessee Cancer Center at Jackson-Madison County General Hospital|
|Jackson, Tennessee, United States, 38301|
|Baptist Regional Cancer Center at Baptist Riverside|
|Knoxville, Tennessee, United States, 37901|
|MBCCOP - Meharry Medical College - Nashville|
|Nashville, Tennessee, United States, 37208-3599|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Study Chair:||Barbara Murphy, MD||Vanderbilt-Ingram Cancer Center|