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Status:

COMPLETED

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

Lead Sponsor:

Vanderbilt-Ingram Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Head and Neck Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief 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. Drugs u...

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 ...

Eligibility Criteria

Inclusion

  • 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)

Exclusion

    Key Trial Info

    Start Date :

    August 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2009

    Estimated Enrollment :

    25 Patients enrolled

    Trial Details

    Trial ID

    NCT00425750

    Start Date

    August 1 2005

    End Date

    June 1 2009

    Last Update

    November 16 2011

    Active Locations (7)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (7 locations)

    1

    Jennie Stuart Medical Center

    Hopkinsville, Kentucky, United States, 42240-2400

    2

    Purchase Cancer Group - Paducah

    Paducah, Kentucky, United States, 42001

    3

    Tennessee Plateau Oncology - Crossville

    Crossville, Tennessee, United States, 38555

    4

    West Tennessee Cancer Center at Jackson-Madison County General Hospital

    Jackson, Tennessee, United States, 38301