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A Phase II Trial of a Protease Inhibitor, Nelfinavir (NFV), Given With Definitive, Concurrent Chemoradiotherapy (CTRT) in Patients With Locally-Advanced, Human Papilloma Virus (HPV) Negative, Squamous Cell Carcinoma of the Head and Neck

NCT02207439

Description:

This is a Phase II trial of definitive chemoradiotherapy (CTRT) given with the protease inhibitor,Nelfinavir (NFV), in patients with locally advanced head and neck. Eligible patients will receive a "lead-in" period of Nelfinavir (1250 mg po bid) for 7-14 days prior to initiation of CTRT. Nelfinavir will then be given concurrently with platinum-based chemotherapy and radiation therapy (planned total dose of 70 Gy over 7 weeks).

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

A Phase II Trial of a Protease Inhibitor, Nelfinavir (NFV), Given With Definitive, Concurrent Chemoradiotherapy (CTRT) in Patients With Locally-Advanced, Human Papilloma Virus (HPV) Negative, Squamous Cell <span class="go-doc-concept go-doc-disease">Carcinoma</span> Larynx

Title

  • Brief Title: A Phase II Trial of a Protease Inhibitor, Nelfinavir (NFV), Given With Definitive, Concurrent Chemoradiotherapy (CTRT) in Patients With Locally-Advanced, Human Papilloma Virus (HPV) Negative, Squamous Cell Carcinoma Larynx
  • Official Title: A Phase II Trial of a Protease Inhibitor, Nelfinavir (NFV), Given With Definitive, Concurrent Chemoradiotherapy (CTRT) in Patients With Locally-Advanced, Human Papilloma Virus (HPV) Negative, Squamous Cell Carcinoma Larynx
  • Clinical Trial IDs

    NCT ID: NCT02207439

    ORG ID: UPCC 15313

    Trial Conditions

    Stage III, IVa, or IVb Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Larynx, or Hypopharynx

    Trial Interventions

    Drug Synonyms Arms
    Nelfinavir (Viracept) 1250 mg Single Arm Phase 2

    Trial Purpose

    This is a Phase II trial of definitive chemoradiotherapy (CTRT) given with the protease
    inhibitor,Nelfinavir (NFV), in patients with locally advanced head and neck. Eligible
    patients will receive a "lead-in" period of Nelfinavir (1250 mg po bid) for 7-14 days prior
    to initiation of CTRT. Nelfinavir will then be given concurrently with platinum-based
    chemotherapy and radiation therapy (planned total dose of 70 Gy over 7 weeks).

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Single Arm Phase 2 Experimental Nelfinavir (Viracept) 1250 mg

    Eligibility Criteria

    Inclusion Criteria:

    - Patients 18 years old.

    - Histologically confirmed diagnosis of squamous cell carcinoma of the oral cavity,
    oropharynx, larynx, or hypopharynx stages III, IVa, or IVb, p16-negative on
    immunohistochemistry

    - Determined by the treating physician to be a candidate for organ preserving,
    concurrent standard chemotherapy and radiation therapy to the head and neck with
    definitive intent.

    - ECOG Performance Status 0-2

    - Patients must sign an informed consent document that indicates they are aware of the
    investigational nature of the treatment in this protocol as well as the potential
    risks and benefits.

    - The effects of EF5 on the developing human fetus are unknown. For this reason, women
    of childbearing potential and men must agree to use adequate contraception (hormonal
    or barrier method of birth control) prior to study entry, during study, until 1 month
    after completion of the final 18F-EF5 PET/CT scan. Should a woman become pregnant or
    suspect she is pregnant while participating in this study, she should inform her
    treating physician immediately. Serum pregnancy testing will be required for women of
    childbearing potential.

    - Ability to understand and the willingness to sign a written informed consent.

    Exclusion Criteria

    - Prior radiation therapy to the head and neck

    - Prior chemotherapy within the past 5 years

    - Previous therapy with a human immunodeficiency virus (HIV) protease inhibitor

    - Pregnant or lactating patients.

    - Patients with known HIV disease. These patients have a high probability of treatment
    with anti-retroviral therapy which may interact with the nelfinavir.

    - Absolute Neutrophil Count 1500 per mm3

    - Platelet count 100,000 per mm3

    - Serum creatinine > 1.5 times the upper limit of normal

    - Serum AST or ALT > 2 times the upper limit of normal

    - Serum bilirubin > 1.2 mg/dl

    - Weight loss of > 10% over the past 6 months which is due to tumor wasting syndrome

    - Distant metastases

    - Patients receiving the following drugs that are contraindicated with NFV will be
    excluded: Antiarrhythmics:amiodarone, quinidine, Antimycobacterial: rifampin, Ergot
    Derivatives:dihydroergotamine, ergonovine, ergotamine, methylergonovine, Herbal
    Products: St.John's wort (hypericum perforatum), HMG-CoA Reductase Inhibitors:
    lovastatin,simvastatin, Neuroleptic:pimozide, Proton Pump Inhibitors,
    Sedative/Hypnotics: midazolam, triazolam,

    - Patients receiving the following drugs will be clinically evaluated as to whether
    dosage/medication can be changed to permit patient on study: Anti-Convulsants:
    carbamazepine, Phenobarbital, Anti-Convulsant:phenytoin,
    Anti-Mycobacterial:rifabutin, PDE5 Inhibitors: sildenafil, vardenafil, tadalafil,
    HMG-CoA: Reductase Inhibitors: atorvastatin, rosuvastatin, Immuno-suppressants:
    cyclosporine,tacrolimus, sirolimus, Narcotic Analgesic: methadone, Oral
    Contraceptive:ethinyl estradiol, Macrolide Antibiotic:azithromycin, Inhaled/nasal
    steroid fluticasone, Antidepressant: trazodone.

    - Women of childbearing potential who have a positive result on screening urine
    pregnancy test.

    - Subjects with moderate-severe renal disease.

    - History of allergic reactionsattributed to Flagyl (metronidazole), which has a
    chemical structure similar to EF5.

    - Uncontrolled intercurrent illness including, but not limited to symptomatic
    congestive heart failure, unstable angina pectoris, or psychiatric illness/social
    situations that would limit compliance with study requirements.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Number of Adverse Events

    Secondary Outcome Measures

    Trial Keywords