- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01634880
Postoperative Radiotherapy and Panitumumab in High-Risk Salivary Gland Malignancies
Phase II Trial of Postoperative Radiotherapy and Panitumumab in High-Risk Salivary Gland Malignancies
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Specific Aims To determine the recurrence-free survival (primary endpoint), overall survival, local and distant recurrence-free survival, and treatment-related toxicities. Also, the investigators plan to study EGFR-related and immune biomarkers in baseline tumor tissue as well as blood samples obtained prior and after therapy.
Subject Population We will enroll patients with completely resected, locally advanced salivary gland cancers.
Treatment Plan Standard radiation 64-70Gy with 2.0 Gy daily fractions in 6-7 weeks. Panitumumab 2.5 mg/Kg IV, weekly during radiation (total of 6-7 doses).
Statistical Design and Sample Size Phase II, one-stage, study with the 3-year recurrence-free survival (RFS) as the primary endpoint. The sample size is 30 patients.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Texas
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San Antonio, Texas, United States, 78229
- Cancer Therapy and Research Center at UTHSCSA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 or stage IVA or IVB.
- No distant metastasis.
- No prior chemotherapy, biological-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.
- No prior invasive malignancy unless the disease-free survival 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 research related treatment.
- 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.
- All WOCBP must have a negative serum pregnancy test at baseline, or within 7 days prior to receiving investigational product. All WOCBP should be instructed to contact the Investigator if they suspect they might be pregnant.
- Prior severe infusion reaction to a human monoclonal antibody.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Postoperative Radiotherapy and Panitumumab
|
The starting panitumumab dose is 2.5 mglkg given once a week. The total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose will be calculated based on the subject's actual weekly body weight. Standard radiation 64-70Gy with 2.0 Gy daily fractions in 6-7 weeks. Panitumumab 2.5 mg/Kg IV, weekly during radiation (total of 6-7 doses). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence-free survival
Time Frame: 5-7 years
|
To evaluate the recurrence-free survival of locoregionally-advanced (stages III/IV) salivary gland cancer patients undergoing postoperative chemoradiotherapy with panitumumab compared to historical control data.
Survival measured by RECIST criteria and analyzed using the Kaplan-Meier method.
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5-7 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 5-7 years
|
Overall survival will be measure via RECIST criteria and analyzed using the Kaplan-Meier method.
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5-7 years
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Efficacy
Time Frame: 5 years
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Correlate efficacy parameters with EGFR and downstream pathway activation,FcyR polymorphisms, and serum cytokine profiles.
More specifically, the aim is to demonstrate the usefulness of biomarkers (downstream signaling molecules, FcyR polymorphisms, or tumor and serum cytokine(s) in predicting recurrence-free survival in patients with salivary gland cancer treated with the above treatment.
|
5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Athanassios Argiris, MD, University of Texas Health Science Center San Antonio
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTRC 11-37
- HSC20120130H (Other Identifier: UTHSCSA IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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