Trial of Radiotherapy and Panitumumab in Salivary Gland Malignancies

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00984217
• Date of registration: 23/09/2009
• Primary sponsor: University of Pittsburgh
• Public title: Trial of Radiotherapy and Panitumumab in Salivary Gland Malignancies
• Scientific title: Phase II Trial of Postoperative Radiotherapy and Panitumumab in High-risk Salivary Gland Malignancies
• Date of first enrolment: August 2011
• Target sample size: 30
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT00984217
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Michael K. Gibson, MD
• Affiliation: University of Pittsburgh

Key inclusion & exclusion criteria

Inclusion Criteria:

- Pathologically determined salivary gland cancer of the major or minor salivary glands
of the head and neck (any histology) status post potentially curative surgical
resection with no macroscopic residual disease. Patients should have AJCC 6th edition
stage III with:

1. extracapsular extension,

2. perineural invasion,

3. positive surgical margins or

4. high grade histology (i.e., high grade mucoepidermoid carcinoma, adenocarcinoma
except basal cell adenocarcinoma, salivary duct carcinoma, squamous cell
carcinoma, or adenoid cystic carcinoma) or stage IVA or IVB.

- No distant metastasis.

- 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.

- No more than 10 weeks (minimum of 3 weeks) should elapse between surgery and
treatment on study.

- ECOG performance status of 0-2

- Patients must have normal organ and marrow function as defined below:

- Absolute neutrophil count: Greater than or equal to 1500/uL

- Platelets: Greater than or equal to 100,000/uL

- Hemoglobin: Greater than or equal to 10g/dL

- Total bilirubin: < 1.5x normal institutional limits

- Creatinine clearance: > 45 mL/min

- Magnesium level: > lower limit normal

- No prior invasive malignancy unless the disease-free survival is 3 years or more.

- Age greater than or equal to 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.

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 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.

- 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.

- Prior radiotherapy, chemotherapy or EGFR inhibitor for head and neck cancer.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Adenoma, Pleomorphic

Mixed Salivary Gland Tumor

Salivary Gland Tumor, Mixed

Syringoma, Chondroid

Intervention(s)

Drug: Panitumumab

Radiation: Radiation

Primary Outcome(s)

To evaluate the recurrence-free survival of advanced salivary gland cancer patients undergoing postoperative chemoradiotherapy with panitumumab compared to historical control data [Time Frame: 3 years]

Secondary Outcome(s)

To collect tumor tissue from pretreatment biopsies for cytokine/chemokine and immune biomarker studies on tumor tissue. [Time Frame: 3 years]

To correlate efficacy parameters with a) EGFR and downstream pathway activation, b) FcyR polymorphisms, and c) serum cytokine profiles. [Time Frame: 3 years]

To evaluate the overall survival, local recurrence-free survival, distant recurrence-free survival and toxicities. [Time Frame: 3 years]

Secondary ID(s)

08-112

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Amgen