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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

Phase 2
18 Years
Open (Enrolling)
Non-HPV Locally Advanced Head and Neck Cancer

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Trial Information

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

Inclusion Criteria

Inclusion criteria:

- Patients must have histologically or cytologically confirmed 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 or T3-4 any N0
M0)including no distant metastases (T1, any N or T2N1 are not eligible).

- 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 CT scan, 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-Free survival

Outcome Description:

The time from randomization until local, regional, or distant disease progression, or death.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Stuart Wong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical College of Wisconsin


United States: Food and Drug Administration

Study ID:




Start Date:

November 2012

Completion Date:

November 2018

Related Keywords:

  • Non-HPV Locally Advanced Head and Neck Cancer
  • Head and Neck Neoplasms



University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
Medical College of Wisconsin Milwaukee, Wisconsin  53226
University Hospitals of Cleveland Cleveland, Ohio  44106
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
City of Hope Comprehensive Cancer Center Duarte, California  91010
University of Texas Southwestern Medical School Dallas, Texas  75235-9032
James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky  40202
Stanford Cancer Center Stanford, California  94305-5824
University of California San Francisco San Francisco, California  941104206
University of Rochester Rochester, New York  14642
Ohio State University Medical Center Columbus, Ohio  43210
University of California, San Diego La Jolla, California  92037-1709
Emory Crawford Long Hospital Atlanta, Georgia  30308
Fox Chase Cancer Center Buckingham Furlong, Pennsylvania  18925
Radiological Associates - Sacramento Sacramento, California  95816