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

Completed · Phase 2 · Has a placebo group

Conditions studied: Non-HPV Locally Advanced Head and Neck Cancer

In brief

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 human papillomavirus (HPV).

Key facts

Study ID: NCT01711658
Run by: Radiation Therapy Oncology Group
People needed: 142
Starts: 2013-03-15
Expected to finish: 2022-09-21
Last updated by the study team: 2023-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 N3 p16 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 ears, nose, throat (ENT) or Head \& Neck Surgeon including laryngopharyngoscopy prior to entering the study.
Patients must have a chest CT scan, or positron emission tomography (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 echocardiogram (ECHO) or multigated acquisition (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
Aspartate aminotransferase (AST) or alanine aminotransferase (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 may not qualify 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 epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor 2 (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 Centers for Disease Control and Prevention (CDC) definition

Where it is running

University of Alabama at Birmingham Comprehensive Cancer Center — Birmingham, Alabama, United States
University of California, San Diego — La Jolla, California, United States
Sutter General Hospital — Sacramento, California, United States
University of California San Francisco — San Francisco, California, United States
Yale University — New Haven, Connecticut, United States
Emory University — Atlanta, Georgia, United States
James Graham Brown Cancer Center at University of Louisville — Louisville, Kentucky, United States
University Hospitals of Cleveland — Cleveland, Ohio, United States
Ohio State University Medical Center — Columbus, Ohio, United States
University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
Fox Chase Cancer Center Buckingham — Furlong, Pennsylvania, United States
University of Texas Southwestern Medical School — Dallas, Texas, United States
University of Texas - MD Anderson Cancer Center — Houston, Texas, United States
University of Wisconsin Comprehensive Cancer Center — Madison, Wisconsin, United States
Medical College of Wisconsin — Milwaukee, Wisconsin, United States
McGill Cancer Centre at McGill University — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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