Bortezomib and Docetaxel in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
- Conditions
- Head and Neck Cancer
- Interventions
- Registration Number
- NCT00425750
- Lead Sponsor
- Vanderbilt-Ingram Cancer Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment bortezomib 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. Treatment docetaxel 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. Treatment laboratory biomarker analysis 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. Treatment pharmacological study 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.
- Primary Outcome Measures
Name Time Method Patient Response to Treatment 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.
- Secondary Outcome Measures
Name Time Method Overall Survival 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 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)
Trial Locations
- Locations (7)
Purchase Cancer Group - Paducah
🇺🇸Paducah, Kentucky, United States
MBCCOP - Meharry Medical College - Nashville
🇺🇸Nashville, Tennessee, United States
Baptist Regional Cancer Center at Baptist Riverside
🇺🇸Knoxville, Tennessee, United States
West Tennessee Cancer Center at Jackson-Madison County General Hospital
🇺🇸Jackson, Tennessee, United States
Jennie Stuart Medical Center
🇺🇸Hopkinsville, Kentucky, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Tennessee Plateau Oncology - Crossville
🇺🇸Crossville, Tennessee, United States