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A Phase II Trial of Postoperative Radiation, Cisplatin, and Panitumumab in Locally Advanced Head and Neck Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

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.


Inclusion Criteria:



- 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 7 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

- 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.

Exclusion Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

8 weeks

Safety Issue:

Yes

Principal Investigator

Robert Ferris, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Institutional Review Board

Study ID:

06-120

NCT ID:

NCT00798655

Start Date:

November 2007

Completion Date:

November 2014

Related Keywords:

  • Head and Neck Cancer
  • panitumumab
  • cisplatin
  • Head and Neck Neoplasms

Name

Location

University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213