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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara Murphy, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00425750
First received: January 19, 2007
Last updated: November 7, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Head and Neck Cancer
Drug: bortezomib
Drug: docetaxel
Other: laboratory biomarker analysis
Other: pharmacological study
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Patient Response to Treatment [ Time Frame: 7.55 months (average duration, on study to off study) ] [ Designated as safety issue: No ]
    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:
  • Overall Survival [ Time Frame: 7.55 months (average duration, on study to off study) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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)


Enrollment: 25
Study Start Date: August 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment

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
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
Blood collection.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425750

Locations
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
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Study Chair: Barbara Murphy, MD Vanderbilt-Ingram Cancer Center
  More Information

Publications:
Responsible Party: Barbara Murphy, Professor of Medicine; Director, Cancer Supportive Care Program; Director, Head and Neck Research Program; Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00425750     History of Changes
Other Study ID Numbers: VICC HN 0501, P30CA068485, VU-VICC-HN-0501, MILLENIUM-X05170, VU-VICC-IRB-050183
Study First Received: January 19, 2007
Results First Received: March 7, 2011
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt-Ingram Cancer Center:
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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Bortezomib
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014