Bortezomib and Docetaxel in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: bortezomib; docetaxel; laboratory biomarker analysis; pharmacological study
Intervention description: 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.
Intervention MeSH terms: Docetaxel; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
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

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 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.
    

Eligibility 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)