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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA068485 | U.S. NIH Grant/Contract | View source | |
| VU-VICC-HN-0501 | |||
| MILLENIUM-X05170 | |||
| VU-VICC-IRB-050183 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bortezomib | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Median survival time of patients, calculated as on-study date to date of death or off-study date (censored) | 7.55 months (average duration, on study to off study) |
| Progression-free Survival |
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DISEASE CHARACTERISTICS:
Diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
Measurable disease
Not a candidate for curative therapy
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
Absolute neutrophil count ≥ 1,500/mm³
Hemoglobin ≥ 8.0 g/dL
Platelet count ≥ 100,000/mm³
AST, ALT, and alkaline phosphatase (AP) meeting 1 of the following criteria:
Bilirubin normal
Creatinine clearance ≤ 2.0 mg/dL
No peripheral neuropathy ≥ grade 2 within the past 28 days
No myocardial infarction within the past 6 months
No New York Heart Association class III or IV heart failure
No uncontrolled angina
No severe uncontrolled ventricular arrhythmias
No electrocardiographic evidence of acute ischemia or active conduction system abnormalities
No known hypersensitivity to bortezomib, boron, or mannitol
No known severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
No serious medical or psychiatric illness that would preclude study participation
No other malignancy within the past 3 years except for early-stage nonmelanomatous skin cancer, carcinoma in situ of the cervix, or early-stage prostate cancer
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Murphy, MD | Vanderbilt-Ingram Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jennie Stuart Medical Center | Hopkinsville | Kentucky | 42240-2400 | United States | ||
| Purchase Cancer Group - Paducah |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19850643 | Result | Chung CH, Aulino J, Muldowney NJ, Hatakeyama H, Baumann J, Burkey B, Netterville J, Sinard R, Yarbrough WG, Cmelak AJ, Slebos RJ, Shyr Y, Parker J, Gilbert J, Murphy BA. Nuclear factor-kappa B pathway and response in a phase II trial of bortezomib and docetaxel in patients with recurrent and/or metastatic head and neck squamous cell carcinoma. Ann Oncol. 2010 Apr;21(4):864-870. doi: 10.1093/annonc/mdp390. Epub 2009 Oct 22. | |
| 25081901 | Derived |
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Twenty-seven patients consented, two of which were ineligible.
This study was open to accrual from 8/25/2005 through 5/20/2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bortezomib; Docetaxel | Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| docetaxel | Drug | 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. |
|
| laboratory biomarker analysis | Other | Tissue and blood collection. |
|
| pharmacological study | Other | Blood collection. |
|
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)
| 7.55 months (average duration, on study to off study) |
| Paducah |
| Kentucky |
| 42001 |
| United States |
| Tennessee Plateau Oncology - Crossville | Crossville | Tennessee | 38555 | United States |
| West Tennessee Cancer Center at Jackson-Madison County General Hospital | Jackson | Tennessee | 38301 | United States |
| Baptist Regional Cancer Center at Baptist Riverside | Knoxville | Tennessee | 37901 | United States |
| MBCCOP - Meharry Medical College - Nashville | Nashville | Tennessee | 37208-3599 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6838 | United States |
| Chung CH, Lee JW, Slebos RJ, Howard JD, Perez J, Kang H, Fertig EJ, Considine M, Gilbert J, Murphy BA, Nallur S, Paranjape T, Jordan RC, Garcia J, Burtness B, Forastiere AA, Weidhaas JB. A 3'-UTR KRAS-variant is associated with cisplatin resistance in patients with recurrent and/or metastatic head and neck squamous cell carcinoma. Ann Oncol. 2014 Nov;25(11):2230-2236. doi: 10.1093/annonc/mdu367. Epub 2014 Jul 31. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bortezomib; Docetaxel | Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 7.55 months (average duration, on study to off study) |
|
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| |||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Median survival time of patients, calculated as on-study date to date of death or off-study date (censored) | Posted | Median | 95% Confidence Interval | Month | 7.55 months (average duration, on study to off study) |
|
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| Secondary | Progression-free Survival | 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) | Posted | Median | 95% Confidence Interval | Month | 7.55 months (average duration, on study to off study) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bortezomib; Docetaxel | Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV 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. | 11 | 25 | 0 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders |
| |||
| Vomitting | Gastrointestinal disorders |
| |||
| Hypercalcemia | Metabolism and nutrition disorders |
| |||
| Seizure | Nervous system disorders |
| |||
| Diarrhea | Gastrointestinal disorders |
| |||
| Dry mouth | Gastrointestinal disorders |
| |||
| Mucositis | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Hemorrhage, GI | Gastrointestinal disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara Murphy, M.D. | Vanderbilt-Ingram Cancer Center | 615-343-4677 |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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| Title | Measurements |
|---|---|
|
| Not Evaluable |
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