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Status:

COMPLETED

Bortezomib, Cetuximab, and Radiation Therapy With or Without Cisplatin in Treating Patients With Stage IV Head and Neck Cancer

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Head and Neck Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Som...

Detailed Description

OBJECTIVES: Primary * To evaluate the feasibility and toxicity of bortezomib, cetuximab, and radiotherapy with or without cisplatin in patients with stage IV squamous cell carcinoma of the head and ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed squamous cell carcinoma of the head and neck, including variants or undifferentiated/poorly differentiated carcinoma
  • Previously untreated stage IV disease OR residual disease or regionally recurrent disease after prior surgery and/or chemotherapy
  • Must be eligible to receive full-dose radiotherapy and be evaluated and accepted for treatment by a Radiation Oncologist
  • No clinically measurable distant disease OR has asymptomatic small distant lesions outside the radiation field ≤ 3 cm in individual or aggregate diameter for which palliation of local and regional disease is clearly warranted
  • No previously untreated nasopharyngeal cancer (any stage)
  • Recurrent nasopharyngeal carcinoma allowed
  • No known brain metastases
  • PATIENT CHARACTERISTICS:
  • ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
  • ANC ≥ 1,500/mcL
  • Platelet count ≥ 100,000/mcL
  • Total bilirubin normal (indirect bilirubin ≤ 3 mg/dL in patients with Gilbert's syndrome)
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Creatinine normal OR creatinine clearance ≥ 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Adequate cognitive and neurologic function
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib, cetuximab, cisplatin, or other agents used in this study
  • No peripheral sensory neuropathy ≥ grade 2
  • No concurrent uncontrolled illness including, but not limited to, the following:
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Psychiatric illness/social situations that would preclude study compliance
  • HIV-negative
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • Recovered from prior therapy
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
  • More than 3 months since prior cisplatin
  • No prior radiotherapy to the head and neck
  • No prior systemic EGFR inhibitors
  • No prior bortezomib
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  • No concurrent antiretroviral therapy
  • No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
  • No concurrent amifostine

Exclusion

    Key Trial Info

    Start Date :

    October 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    46 Patients enrolled

    Trial Details

    Trial ID

    NCT00629226

    Start Date

    October 1 2007

    Last Update

    September 30 2011

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

    Bethesda, Maryland, United States, 20892-1182

    2

    UPMC Cancer Centers

    Pittsburgh, Pennsylvania, United States, 15232