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Head and Neck CancerPhase 2NCT00425750

Bortezomib and Docetaxel in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

A Phase 2 study testing bortezomib, docetaxel and laboratory biomarker analysis in people with Head and Neck Cancer, run by Vanderbilt-Ingram Cancer Center at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
bortezomib, docetaxel and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
7 sitesUnited States
Study dates
Aug 2005to Jun 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
  • Recurrent or metastatic disease
  • 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:
  • AP normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)
  • AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN
  • AP ≤ 5 times ULN AND AST and ALT normal
  • 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:

  • No prior chemotherapy for recurrent or metastatic disease
  • At least 28 days since prior and no other concurrent investigational drugs
  • No other concurrent anticancer therapy
  • No other concurrent chemotherapy
  • No concurrent complementary or herbal medicine
  • No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Tennessee Plateau Oncology - Crossville

    Crossville, Tennessee, 38555

  • Jennie Stuart Medical Center

    Hopkinsville, Kentucky, 42240-2400

  • West Tennessee Cancer Center at Jackson-Madison County General Hospital

    Jackson, Tennessee, 38301

  • Baptist Regional Cancer Center at Baptist Riverside

    Knoxville, Tennessee, 37901

  • MBCCOP - Meharry Medical College - Nashville

    Nashville, Tennessee, 37208-3599

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

  • Purchase Cancer Group - Paducah

    Paducah, Kentucky, 42001

Other trials in United States

About this study

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)

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.

Read the 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.

Being tested
bortezomib, docetaxel, laboratory biomarker analysis, pharmacological study
Keywords
stage IV squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bortezomibDrug

    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.

  • docetaxelDrug

    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 analysisOther

    Tissue and blood collection.

  • pharmacological studyOther

    Blood collection.

Study groups in NCT00425750
Study groupRoleWhat they receive
TreatmentExperimentalDocetaxel (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.
Receives: Drug: bortezomib; Drug: docetaxel; Other: laboratory biomarker analysis; Other: pharmacological study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 7.55 months (average duration, on study to off study)

Secondary outcomes (2)

  1. Overall Survival

    Median survival time of patients, calculated as on-study date to date of death or off-study date (censored)

    Measured: 7.55 months (average duration, on study to off study)

  2. 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)

    Measured: 7.55 months (average duration, on study to off study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2007 (estimated)
  2. Study startAug 2005
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00425750
Sponsor's protocol ID
VICC HN 0501
Other IDs
P30CA068485, VU-VICC-HN-0501, MILLENIUM-X05170, VU-VICC-IRB-050183
Status last verified
Nov 2011
First submitted
19 Jan 2007
Last updated
16 Nov 2011
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19850643

  • 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.

    PubMed 25081901

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bortezomib, docetaxel and laboratory biomarker analysis in people with Head and Neck Cancer, run by Vanderbilt-Ingram Cancer Center at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Response to Treatment (time frame: 7.55 months (average duration, on study to off study)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00425750, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2011.

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