Standard therapy for high-risk or locally advanced salivary gland malignancies is surgery followed by postoperative radiation therapy. Retrospective studies have shown the superiority of combined modality therapy compared to surgery alone for patients with advanced T or N stage. Despite the addition of postoperative radiation therapy, the five-year survival for locally advanced salivary gland malignancies is poor (less than 60%). In salivary gland malignancies, the epidermal growth factor receptor (EGFR) is expressed in 25-85%; in certain histological types, like salivary duct carcinomas, the expression is higher. EGFR is a promising target of anticancer therapy. In squamous cell carcinoma of the head and neck, a phase III trial utilizing cetuximab added to radiation therapy improved both locoregional control and overall survival compared to radiation alone. Panitumumab is a novel, human, IgG2 EGFR monoclonal antibody that may be better tolerated and more efficacious than cetuximab. Here, the investigators suggest that the addition of panitumumab to standard radiotherapy in locally-advanced salivary gland malignancies will improve recurrence-free survival (RFS).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Radiation 64-70Gy (2.0 Gy/day, 5 days/week)
2.5 mg/Kg IV, weekly during RT. 6-7 weeks
UPMC Cancer Center - Teramana Cancer Center - Steubenville
Steubenville, Ohio, United States
UPMC Cancer Center - Beaver
Beaver, Pennsylvania, United States
UPMC Cancer Center - Clairton
Clairton, Pennsylvania, United States
UPMC Cancer Center - Arnold Palmer Pavilion - Greensburg
Greensburg, Pennsylvania, United States
UPMC Cancer Center - Oakbrook Commons - Greensburg
Greensburg, Pennsylvania, United States
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
To evaluate the overall survival, local recurrence-free survival, distant recurrence-free survival and toxicities.
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 collect tumor tissue from pretreatment biopsies for cytokine/chemokine and immune biomarker studies on tumor tissue.
Time frame: 3 years
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UPMC Cancer Center - Oakbrook Commons
Greensburg, Pennsylvania, United States
UPMC Cancer Center -Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States
UPMC Cancer Center - Indiana
Indiana, Pennsylvania, United States
UPMC Cancer Center - John P. Murtha Pavilion - Johnstown
Johnstown, Pennsylvania, United States
UPMC Cancer Center - McKeesport
McKeesport, Pennsylvania, United States
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