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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

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

Keywords

Non-HPV Locally Advanced Head and Neck Cancer Lapatinib Cisplatin

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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

Locations

  • Sutter General Hospital
    Sacramento, California, 95816, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Radiation Therapy Oncology Group
ID
NCT01711658
Phase
Phase 2
Study Type
Interventional
Last Updated
July 1, 2017