Clinical Trials /

TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer.

NCT01711658

Description:

PURPOSE: This trial is studying if and how well lapatinib adds to the effectiveness of radiation therapy plus cisplatin in patients who have head and neck cancer that is not related to the HPV virus.

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

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

TRYHARD: <span class="go-doc-concept go-doc-intervention">Radiation</span> Therapy Plus <span class="go-doc-concept go-doc-intervention">Cisplatin</span> With or Without <span class="go-doc-concept go-doc-intervention">Lapatinib</span> in Treating Patients With Head and Neck <span class="go-doc-concept go-doc-disease">Cancer</span>.

Title

  • Brief Title: TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer.
  • Official Title: TRYHARD: A Phase II, Randomized, Double Blind, Placebo-Controlled Study of Lapatinib (Tykerb) for Non-HPV Locally Advanced Head and Neck Cancer With Concurrent Chemoradiation
  • Clinical Trial IDs

    NCT ID: NCT01711658

    ORG ID: RF-3501

    NCI ID: LAP116153

    Trial Conditions

    Non-HPV Locally Advanced Head and Neck Cancer

    Trial Interventions

    Drug Synonyms Arms
    Cisplatin Radiation therapy (IMRT) + cisplatin + placebo, Radiation therapy (IMRT) + cisplatin + lapatinib
    placebo Radiation therapy (IMRT) + cisplatin + placebo
    Lapatinib Radiation therapy (IMRT) + cisplatin + lapatinib

    Trial Purpose

    PURPOSE: This trial is studying if and how well lapatinib adds to the effectiveness of
    radiation therapy plus cisplatin in patients who have head and neck cancer that is not
    related to the HPV virus.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Radiation therapy (IMRT) + cisplatin + placebo Placebo Comparator Radiation therapy: Intensity Modulated Radiation Therapy (IMRT) + cisplatin + placebo Cisplatin, placebo
    Radiation therapy (IMRT) + cisplatin + lapatinib Active Comparator Radiation therapy: Intensity Modulated Radiation Therapy (IMRT) + cisplatin + lapatinib Cisplatin, Lapatinib

    Eligibility Criteria

    Inclusion criteria:

    - Patients must have histologically or cytologically confirmed diagnosis (from primary
    lesion and/or lymph nodes) of Squamous Cell Cancer of the oropharynx, hypopharynx or
    larynx (For patients with oropharynx primary, the tumor must be negative for p16 by
    immunohistochemistry).

    - Patients with selected Stage III or IV disease (T2 N2-3 M0, T3-4 any N M0, T1 N2b,
    N2c or N3p16 negative oropharynx cancer or T1-2 any N hypopharynx cancer) including
    no distant metastases.

    - History/Physical examination by a Radiation Oncologist and Medical oncologist prior
    to entering the study.

    - Examination by an ENT or Head & Neck Surgeon including laryngopharyngoscopy prior to
    entering the study.

    - Patients must have a chest CT scan, or PET/CT scan to rule out metastatic disease

    - Patients must have a contrast enhanced CT scan or MRI or PET/CT scan of the tumor
    site and neck nodes prior to entering the study.

    - Patients must have an EKG and ECHO or MUGA scan prior to entering the study.

    - Patients must have Zubrod Performance Status of 0-1.

    - Patients must be 18 years of age.

    - Patients must have normal organ and marrow function as defined below:

    - Absolute neutrophil count (ANC) 1,500 cells/mm3

    - Platelets 100,000 cells/mm3

    - Hemoglobin 8.0 g/dl

    - Serum creatinine < 1.5 mg/dl or creatinine clearance (CC) 50 ml/min

    - Total bilirubin < 2 x the institutional upper limit of normal

    - AST or ALT 3 x the institutional upper limit of normal

    - Patient must have magnesium, calcium, glucose, potassium and sodium levels within
    normal limits

    - Women of childbearing potential must have a negative pregnancy test prior to
    registration.

    - Patients of reproductive potential must practice effective contraception while on
    study and for at least 60 calendar days following treatment.

    - All patients must sign an informed consent prior to enrollment.

    - Patients must comply with the treatment plan and follow-up schedule.

    Exclusion criteria:

    - Patients with simultaneous primaries or bilateral tumors.

    - Patients who have had gross total excision of the primary tumor.

    - Patients with initial surgical treatment, radical or modified neck dissection.

    - Patients who received prior systemic chemotherapy for the study cancer.

    - Patients who received prior radiotherapy to the region of the study cancer that would
    result in overlap of radiation therapy fields.

    - Patients with primary tumor of oral cavity, nasopharynx, sinuses or salivary glands.

    - Prior allergic reaction to the study drugs.

    - Patients who have had prior therapy that specifically and directly targets the
    EGFR/HER2 pathway.

    - Patients who have current active hepatic or biliary disease (with exception of
    patients with Gilbert's syndrome, asymptomatic gallstones, or stable chronic liver
    disease per investigator assessment);

    - Pregnant women or sexually active patients not willing or able to use medically
    acceptable forms of contraceptive method while on treatment.

    - Patients with severe, active co-morbidity, defined as follows:

    - Uncontrolled cardiac disease, such as uncontrolled hypertension, unstable
    angina, and/or congestive heart failure requiring hospitalization within the
    last 6 months

    - Transmural myocardial infarction within the last 6 months

    - Left ventricular ejection fraction < 45%

    - Acute bacterial or fungal infection requiring intravenous antibiotics at the
    time of registration

    - Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness
    requiring hospitalization or precluding study therapy within 30 calendar days
    prior to registration

    - Hepatic insufficiency resulting in clinical jaundice and/or Coagulation defects

    - Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Progression-Free survival

    Secondary Outcome Measures

    Distant metastasis

    Adverse Events

    Compliance with planned treatment

    Local-regional failure

    Performance Status Scale for Head & Neck Cancer.

    Functional Assessment of Cancer Therapy - Head & Neck.

    University of Michigan Xerostomia-Related Quality of Life Scale.

    HER2, EGFR, EMT as biomarkers of response.

    Overall Survival

    Trial Keywords