TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer.
Conditions
Non-HPV Locally Advanced Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: Intensity Modulated Radiation Therapy (IMRT) Type: Radiation
Name: Cisplatin Type: Drug
Name: placebo Type: Drug
Name: Lapatinib Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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 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 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
Locations
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Status: Recruiting
Contact: Clinical Trials Office - University of Alabama at Birmingham C - 205-934-0309
University of California, San Diego
La Jolla, California, United States
Status: Recruiting
Contact: Loren Mell, MD - lmell@ucsd.edu
Sutter General Hospital
Sacramento, California, United States
Status: Recruiting
Contact: Christopher Jones - jonescu@sutterhealth.org
University of California San Francisco
San Francisco, California, United States
Status: Recruiting
Contact: Sue S Yom, MD, PhD - yoms@radonc.ucsf.edu
Emory University
Atlanta, Georgia, United States
Status: Recruiting
Contact: Jonathan J. Beitler - 404-686-4411
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States
Status: Recruiting
Contact: Neal Dunlap, MD - 502-561-2704
Duke University
Durham, North Carolina, United States
Status: Recruiting
Contact: David Brizel, MD - 919-668-5637
University Hospitals of Cleveland
Cleveland, Ohio, United States
Status: Recruiting
Contact: Min Yao - min.yao@uhhospitals.org
Ohio State University Medical Center
Columbus, Ohio, United States
Status: Recruiting
Contact: Maura L Gillison, MD, PhD - maura.gillison@osumc.edu
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Status: Recruiting
Contact: Terrance Herman, MD - terence-herman@ouhsc.edu
Fox Chase Cancer Center Buckingham
Furlong, Pennsylvania, United States
Status: Recruiting
Contact: Thomas Galloway, MD - thomas.galloway@fccc.edu
University of Texas Southwestern Medical School
Dallas, Texas, United States
Status: Recruiting
Contact: John Yordy, MD, PhD - john.yordy@utsouthwestern.edu
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Contact: Brandon Gunn, MD - gbgunn@mdanderson.org
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Status: Recruiting
Contact: Paul M. Harari - 608-263-8500
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Status: Recruiting
Contact: Stuart Wong, MD - swong@mcw.edu
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada
Status: Recruiting
Contact: George Shenouda - 514-398-1444
Start Date
November 2012
Completion Date
November 2018
Sponsors
Radiation Therapy Oncology Group
Source
Radiation Therapy Oncology Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page