Clinical Trial: Trial of Radiotherapy and Panitumumab in Salivary Gland Malignancies

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Phase II Trial of Postoperative Radiotherapy and Panitumumab in High-risk Salivary Gland Malignancies

Brief Summary: 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).

Detailed Summary:
Sponsor: University of Pittsburgh

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: University of Pittsburgh

Dates:
Date Received: September 23, 2009
Date Started: August 2011
Date Completion:
Last Updated: January 6, 2016
Last Verified: January 2016