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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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

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)


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patient Response to Treatment

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Barbara Murphy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

VICC HN 0501

NCT ID:

NCT00425750

Start Date:

August 2005

Completion Date:

June 2009

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
MBCCOP - Meharry Medical College - NashvilleNashville, Tennessee  37208-3599
West Tennessee Cancer Center at Jackson-Madison County General HospitalJackson, Tennessee  38301
Jennie Stuart Medical CenterHopkinsville, Kentucky  42240
Purchase Cancer Group - PaducahPaducah, Kentucky  42001
Tennessee Plateau Oncology - CrossvilleCrossville, Tennessee  38555
Baptist Regional Cancer Center at Baptist RiversideKnoxville, Tennessee  37901