A Phase 2 interventional study of bortezomib and docetaxel in Head and Neck Cancer, sponsored by Vanderbilt-Ingram Cancer Center. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-11-16.
Sponsored by Vanderbilt-Ingram Cancer Center · Phase 2, Interventional, and Treatment
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 25 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Vanderbilt-Ingram Cancer Center is the lead sponsor of 220 studies on the registry; 32 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
PATIENT CHARACTERISTICS:
AST, ALT, and alkaline phosphatase (AP) meeting 1 of the following criteria:
PRIOR CONCURRENT THERAPY:
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.
Drug: bortezomib · Drug: docetaxel · Other: laboratory biomarker analysis · Other: pharmacological study
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.
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.
Tissue and blood collection.
Blood collection.
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.
Time frame: 7.55 months (average duration, on study to off study)
Overall Survival
Median survival time of patients, calculated as on-study date to date of death or off-study date (censored)
Time frame: 7.55 months (average duration, on study to off study)
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)
Time frame: 7.55 months (average duration, on study to off study)
This study was open to accrual from 8/25/2005 through 5/20/2008.
| Milestone | Bortezomib; Docetaxel |
|---|---|
| Started | 25 |
| Completed | 0 |
| Not completed | 25 |
| Withdrew: Death | 1 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Adverse event | 3 |
| Withdrew: Progression of disease | 18 |
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.
| participants | Bortezomib; Docetaxel |
|---|---|
| Partial Response | 1 |
| Progressive Disease | 10 |
| Stable Disease | 10 |
| Not Evaluable | 4 |
Median survival time of patients, calculated as on-study date to date of death or off-study date (censored)
| Month | Bortezomib; Docetaxel |
|---|---|
| Overall Survival | 5.13 (3.71 to 9.76) |
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)
| Month | Bortezomib; Docetaxel |
|---|---|
| Progression-free Survival | 2.27 (1.61 to 4.70) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bortezomib; Docetaxel | — | 11/25 (44%) | 0/25 (0%) |
| Event | Bortezomib; Docetaxel |
|---|---|
| DeathGeneral disorders | 2/25 |
| VomittingGastrointestinal disorders | 2/25 |
| HypercalcemiaMetabolism and nutrition disorders | 1/25 |
| SeizureNervous system disorders | 1/25 |
| DiarrheaGastrointestinal disorders | 1/25 |
| Dry mouthGastrointestinal disorders | 1/25 |
| MucositisGastrointestinal disorders | 1/25 |
| NauseaGastrointestinal disorders | 1/25 |
| Hemorrhage, GIGastrointestinal disorders | 1/25 |
| Age, Categorical(Participants) | Bortezomib; Docetaxel |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 21 |
| >=65 years | 4 |
| Age Continuous(years) | Bortezomib; Docetaxel |
|---|---|
| Mean | 55 ± 1 |
| Sex: Female, Male(Participants) | Bortezomib; Docetaxel |
|---|---|
| Female | 7 |
| Male | 18 |
| Region of Enrollment(participants) | Bortezomib; Docetaxel |
|---|---|
| United States | 25 |
This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Vanderbilt-Ingram Cancer Center