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Status:

COMPLETED

Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer

Lead Sponsor:

University of Texas Southwestern Medical Center

Conditions:

Head and Neck Cancer

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

Brief Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or c...

Detailed Description

OBJECTIVES: Primary * To evaluate whether treatment with cetuximab, cisplatin, and intensity-modulated radiotherapy improves the overall survival of patients with recurrent squamous cell carcinoma o...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Pathologically confirmed squamous cell carcinoma (SCC) of the upper aerodigestive tract
  • Recurrent disease or second primary SCC
  • Recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence)
  • Majority (≥ 75%) of the recurrent tumor must be in areas previously irradiated to ≥ 45 Gy
  • More than one recurrence allowed provided the first recurrence occurred \> 6 months after the completion of prior radiotherapy
  • Unresectable disease OR has high-risk features after resection (e.g., positive margins and/or extracapsular extension)
  • No signs of carotid exposure
  • No primary nasopharyngeal or salivary gland tumor
  • Equivocal pulmonary nodes on chest CT scan allowed provided they are \< 1 cm, cannot be safely biopsied, or are negative on PET scan
  • No distant metastasis
  • PATIENT CHARACTERISTICS:
  • Karnofsky performance status 70-100%
  • ANC ≥ 2,000/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)
  • Bilirubin \< 1.5 mg/dL
  • AST or ALT \< 2 times upper limit of normal
  • Creatinine clearance ≥ 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to submit prior radiotherapy records to assure that the spinal cord tolerance is not exceeded
  • No active cardiac disease, including any of the following:
  • Unstable angina
  • Uncontrolled hypertension
  • Myocardial infarction within the past 6 months (unless successfully treated with coronary artery bypass graft or percutaneous transluminal coronary angioplasty)
  • Uncontrolled arrhythmia
  • Congestive heart failure
  • At least 3 heart-related hospitalizations within the past year
  • No severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations within the past year
  • No concurrent medical illness that would impair patient tolerance to therapy or limit survival
  • No other invasive malignancy within the past 2 years
  • No pre-existing peripheral sensory neuropathy ≥ grade 2
  • No prior severe infusion reaction to a monoclonal antibody
  • No prisoners or individuals who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • Recovered from prior surgery
  • Prior cisplatin and cetuximab allowed
  • At least 6 months since prior radiotherapy or chemotherapy
  • No prior radiotherapy \> 75 Gy
  • No prior chemotherapy for recurrent head and neck cancer
  • Prior chemotherapy as a component of the primary treatment allowed
  • No prior combination cisplatin, cetuximab, and radiotherapy for recurrent head and neck cancer
  • Patients with a new primary head and neck cancer whose prior primary head and neck cancer was treated with concurrent cisplatin, cetuximab, and radiotherapy are eligible provided it has been \> 6 months since treatment

Exclusion

    Key Trial Info

    Start Date :

    December 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 1 2016

    Estimated Enrollment :

    37 Patients enrolled

    Trial Details

    Trial ID

    NCT00833261

    Start Date

    December 1 2008

    End Date

    May 1 2016

    Last Update

    August 21 2020

    Active Locations (4)

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

    Page 1 of 1 (4 locations)

    1

    University Hospitals of Cleveland

    Cleveland, Ohio, United States, 44106

    2

    Baylor Research Institute

    Dallas, Texas, United States, 75204

    3

    University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, United States, 75390

    4

    Medical College of Wisconsin

    Milwaukee, Wisconsin, United States, 53226