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



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:6/7/2018
Start Date:March 18, 2013
End Date:March 31, 2023

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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

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.


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
We found this trial at
16
sites
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Jonathan Beitler, MD
Phone: 404-686-4411
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Dallas, Texas 75235
Principal Investigator: John Yordy, MD
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Birmingham, Alabama
Principal Investigator: Jennifer De Los Santos, MD
Phone: 205-934-0309
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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Columbus, Ohio 43210
Principal Investigator: Maura Gillison, MD
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Furlong, Pennsylvania 18925
Principal Investigator: Thomas Galloway, MD
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Brandon Gunn, MD
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Principal Investigator: Loren Mell, MD
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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Louisville, Kentucky 40202
Principal Investigator: Neal Dunlap, MD
Phone: 502-561-2704
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Louisville, KY
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Madison, Wisconsin 53792
Principal Investigator: Paul Harari, MD
Phone: 608-263-8500
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Stuart Wong, MD
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Montreal, Quebec
Principal Investigator: George Shenouda, MD
Phone: 514-398-1444
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New Haven, Connecticut 6520
(203) 432-4771
Principal Investigator: Barbara Burtness, MD
Phone: 203-737-7636
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Terrence Herman, MD
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Sacramento, California 95816
Principal Investigator: Christopher Jones, MD
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San Francisco, California 94143
Principal Investigator: Sue Yom, MD
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