Clinical Trials /

Radiation Therapy and Docetaxel in Treating Patients With HPV-Related Oropharyngeal Cancer

NCT01932697

Description:

This phase II trial studies how well radiation therapy and docetaxel work in treating patients with human papillomavirus (HPV)-related oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving radiation therapy with docetaxel my kill more tumor cells.

Related Conditions:
  • Oropharyngeal Squamous Cell Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Radiation Therapy and Docetaxel in Treating Patients With HPV-Related Oropharyngeal Cancer

Title

  • Brief Title: Radiation Therapy and Docetaxel in Treating Patients With HPV-Related Oropharyngeal Cancer
  • Official Title: Phase II Evaluation of Adjuvant Hyperfractionated Radiation and Docetaxel for HPV Associated Oropharynx Cancer
  • Clinical Trial IDs

    NCT ID: NCT01932697

    ORG ID: MC1273

    NCI ID: NCI-2013-01652

    Trial Conditions

    Human Papillomavirus Infection

    Stage I Oropharyngeal Squamous Cell Carcinoma

    Stage II Oropharyngeal Squamous Cell Carcinoma

    Stage III Oropharyngeal Squamous Cell Carcinoma

    Stage IVA Oropharyngeal Squamous Cell Carcinoma

    Stage IVB Oropharyngeal Squamous Cell Carcinoma

    Trial Interventions

    Drug Synonyms Arms
    Docetaxel Docecad, RP56976, Taxotere, Taxotere Injection Concentrate Treatment (docetaxel, hyperfractionated IMRT)

    Trial Purpose

    This phase II trial studies how well radiation therapy and docetaxel work in treating
    patients with human papillomavirus (HPV)-related oropharyngeal cancer. Radiation therapy
    uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel,
    work in different ways to stop the growth of tumor cells, either by killing the cells, by
    stopping them from dividing, or by stopping them from spreading. Giving radiation therapy
    with docetaxel my kill more tumor cells.

    Detailed Description

    PRIMARY OBJECTIVES:

    I. To assess the cumulative incidence of local/regional failure at 2 years after study
    registration.

    SECONDARY OBJECTIVES:

    I. To characterize the rate of acute grade 3 or higher functional mucosal adverse events (up
    to 1 month post-radiation therapy [XRT]) associated with adjuvant docetaxel +
    hyperfractionated radiotherapy (key secondary endpoint).

    II. To assess changes in overall survival, disease-free survival, distant failure rates, and
    quality of life (QOL) associated with adjuvant docetaxel and hyperfractionated radiation.

    III. To characterize other acute adverse events (up to 1 month post-XRT) and late grade 3 or
    higher non-hematologic adverse events (up to 2 years post-XRT) associated with adjuvant
    docetaxel + hyperfractionated radiotherapy.

    TERTIARY OBJECTIVES:

    I. To determine the genetic alterations of oropharynx tumor specimens and the detection rate
    of corresponding cell-free deoxyribonucleic acid (cfDNA) in the pre-surgical, post-surgical,
    and post-radiation blood of oropharynx cancer patients.

    OUTLINE:

    Patients receive docetaxel intravenously (IV) over 1 hour on days 1 and 8 and undergo
    hyperfractionated intensity-modulated radiation therapy (IMRT) twice daily (BID) 5 days a
    week on days 1-12 for a total of 20 fractions.

    After completion of study treatment, patients are followed up at 14 days, 1 month, every 3
    months for 2 years, every 6 months for 1 year and then annually for 2 years.

    Trial Arms

    Name Type Description Interventions
    Treatment (docetaxel, hyperfractionated IMRT) Experimental Patients receive docetaxel IV over 1 hour on days 1 and 8 and undergo hyperfractionated IMRT BID 5 days a week on days 1-12 for a total of 20 fractions. Docetaxel

    Eligibility Criteria

    Inclusion Criteria:

    - PRE-REGISTRATION

    - Provide written informed consent

    - Submission of research blood draw to be stored until after surgical resection of the
    primary tumor and confirmation of human papilloma virus (HPV) positivity (Mayo Clinic
    Rochester patients only)

    - Patients with oropharynx carcinoma with a smoking history of 10 pack-year or
    equivalent 10 year history of tobacco product use and no recent history (within last
    5 years) of tobacco use

    - REGISTRATION

    - Histological confirmation of HPV+ squamous cell carcinoma of the oropharynx; HPV
    positivity will be defined as positive staining for p16 on immunohistochemistry (IHC)

    - Gross total surgical resection with curative intent of the primary tumor and at least
    unilateral neck dissection within 7 weeks of registration

    - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

    - Smoking history < 10 pack years or equivalent 10 year history of tobacco product use

    - Absence of distant metastases on standard diagnostic work-up =< 10 weeks prior to
    registration; (chest computed tomography [CT], chest x-ray [CXR], positron emission
    tomography [PET]/CT, etc.)

    - Must have one of the following risk factors:

    - Lymph node > 3 cm

    - 2 or more positive lymph nodes

    - Perineural invasion

    - Lymphovascular space invasion

    - T3 or microscopic T4a primary disease

    - Lymph node extracapsular extension

    - Absolute neutrophil count (ANC) >= 1500/mm^3

    - Platelet count >= 100,000/mm^3

    - Hemoglobin >= 9.0 g/dL

    - Direct bilirubin within upper limit of normal (ULN)

    - Creatinine =< ULN x 1.5

    - Negative pregnancy test done =< 7 days prior to registration, for women of
    childbearing potential only

    - Ability to complete questionnaire(s) by themselves or with assistance

    - Provide informed written consent

    - Willingness to return to enrolling institution for follow-up (during the active
    monitoring phase of the study)

    Exclusion Criteria:

    - Any significant tobacco history within the past five years

    - Any of the following:

    - Pregnant women

    - Nursing women

    - Men or women of childbearing potential who are unwilling to employ adequate
    contraception

    - Co-morbid systemic illnesses or other severe concurrent disease which, in the
    judgment of the investigator, would make the patient inappropriate for entry into
    this study or interfere significantly with the proper assessment of safety and
    toxicity of the prescribed regimens

    - Immunocompromised patients and patients known to be human immunodeficiency virus
    (HIV) positive

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

    - Receiving any other investigational agent which would be considered as a treatment
    for the primary neoplasm

    - Other active malignancy =< 5 years prior to registration; EXCEPTIONS: non-melanotic
    skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history or prior
    malignancy, they must not be receiving other specific treatment for their cancer

    - History of myocardial infarction =< 180 days prior to registration, or congestive
    heart failure requiring use of ongoing maintenance therapy for life-threatening
    ventricular arrhythmias

    - Prior history of radiation therapy to the affected site

    - History of connective tissue disorders such as rheumatoid arthritis, lupus, or
    Sjogren's disease

    - Presence of any of the following risk factors after surgery:

    - Any positive surgical margin

    - Adenopathy below the clavicles

    - Prior systemic chemotherapy for the study cancer; NOTE: prior chemotherapy for a
    different cancer is allowable

    - History of allergic reaction to docetaxel

    - Receiving any medications or substances that are strong or moderate inhibitors of
    cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4)

    - Use of strong or moderate inhibitors is prohibited =< 7 days prior to
    registration

    - Receiving any medications or substances that are inducers of CYP3A4

    - Use of inducers is prohibited =< 12 days prior to registration

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Cumulative incidence of local/regional failure

    Secondary Outcome Measures

    Change in QOL measured using the Xerostomia- Related Quality of Life Scale (XeQOLS) form, European Quality of Life (EuroQol) 5D (Eq-5D), Functional Assessment of Cancer Therapy Head and Neck (FACT H& N) (version 4), and Dermatology Life Quality Index

    Change in swallowing studies

    Disease-free survival (DFS)

    Distant failure rates

    Incidence of acute adverse events graded according to NCI CTCAE version 4.0

    Incidence of acute grade 3 or higher functional mucosal adverse events graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

    Incidence of late adverse events graded according to NCI CTCAE version 4.0

    Overall survival (OS)

    Trial Keywords