A Phase II Trial of Postoperative Radiation, Cisplatin, and Panitumumab in Locally Advanced Head and Neck Cancer
Pathologically staged squamous cell carcinoma of the head and neck, stage III or IVa (AJCC
6th edition 2002) of the oral cavity, larynx, or hypopharynx that is status post potentially
curative surgical resection without gross residual tumor, except the following: a)T3N0
laryngeal primary and b) any T1N1, if there are no high-risk pathologic features (high risk
defined as positive margins, extracapsular spread, and perineural or angiolymphatic
invasion). Patients should not have gross residual disease. No prior chemotherapy,
biologic/targeted therapy (including any prior therapy which specifically and directly
targets the EGFR pathway), or radiotherapy for head and neck cancer. A brief course, up to 2
weeks, of prior neoadjuvant single-agent biologic/targeted therapy of any type (except EGFR
monoclonal antibodies) prior to surgical resection is permitted. No more than 6 weeks
(minimum of 3 weeks) should have elapsed between surgery and initiation of radiation. No
prior radiation or chemotherapy for head and neck cancer. ECOG performance status of 0-1.
Patients must have normal organ and marrow function as defined below: absolute neutrophil
count >=1,500/mL; Platelets >=100,000/mL; Hemoglobin >=10 g/dL; Total bilirubin 1.5 x normal
institutional limits; Creatinine clearance > 60 ml/min. No prior invasive malignancy unless
the DFS is 3 years or more. Age >= 18 years. Pregnant or breast-feeding women are excluded
(see exclusion criteria). Informed consent must be obtained from all patients prior to
beginning therapy. Patients should have the ability to understand and the willingness to
sign a written informed consent document. Patients who have tumor tissue available from
previous diagnostic or therapeutic procedures should submit the specimen for assessment of
EGFR and related biomarkers after signing informed consent. In-Eligibility: Uncontrolled
intercurrent illness including, but not limited to, ongoing or active infection or
psychiatric illness/social situations that would limit compliance with study requirements.
Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension,
unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled
congestive heart failure, and cardiomyopathy with decreased ejection fraction. All patients
will have a baseline EKG. If abnormalities consistent with active coronary artery disease
are detected, the patient will be referred to a cardiologist for appropriate evaluation and
management prior to treatment on study. Patients may not be receiving any other
investigational agents. No history of prior malignancy, with the exception of curatively
treated squamous cell or basal carcinoma of the skin or in situ cervical cancer, or
malignancy that has been treated with a curative intent with a 3-year disease-free survival.
No patients with significant baseline sensory or motor neurologic deficits (> grade I
neuropathy) will be treated on this study. Pregnant women are excluded from this study
because chemotherapy and radiation therapy have the potential for teratogenic or
abortifacient effects. Because there is an unknown but potential risk for adverse events in
nursing infants secondary to treatment of the mother with chemotherapy, breastfeeding should
be discontinued if the mother is treated with chemotherapy. Prior to study enrollment, women
of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy
during trial participation and the potential risk factors for an unintentional pregnancy. In
addition, men enrolled on this study should understand the risks to any sexual partner of
childbearing potential and should practice an effective method of birth control. All WOCBP
MUST have a negative urine pregnancy test at baseline, or within 7 days prior to receiving
investigational product. The minimum sensitivity of the pregnancy test must be 25 IU/L or
equivalent units of HCG. If the urine pregnancy test is positive, a serum pregnancy test
will then be performed to confirm the result. In the event that both the urine and serum
pregnancy tests are positive, the subject must not receive investigational product and must
not be enrolled in the study. In addition, all WOCBP should be instructed to contact the
Investigator immediately if they suspect they might be pregnant (e.g., missed or late
menstrual period) at any time during study participation. The Investigator must immediately
notify Amgen in the event of a confirmed pregnancy in a patient participating in the study.
Prior severe infusion reaction to a human monoclonal antibody.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the progression-free survival (primary endpoint) and overall survival, and treatment toxicities. Also, we plan to study EGFR-related and immune biomarkers in baseline tumor tissue as well as blood samples obtained prior and after therapy.
8 weeks
Yes
Robert Ferris, MD
Principal Investigator
University of Pittsburgh
United States: Institutional Review Board
06-120
NCT00798655
November 2007
November 2014
Name | Location |
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University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |