Adenoma, Pleomorphic, Mixed Salivary Gland Tumor, Salivary Gland Tumor, Mixed, Syringoma, Chondroid
Conditions
Keywords
panitumumab, salivary gland malignancies, radiotherapy
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).
Interventions
RADIATIONRadiation
Radiation 64-70Gy (2.0 Gy/day, 5 days/week)
DRUGPanitumumab
2.5 mg/Kg IV, weekly during RT. 6-7 weeks
Sponsors
Amgen
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the recurrence-free survival of advanced salivary gland cancer patients undergoing postoperative chemoradiotherapy with panitumumab compared to historical control data | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the overall survival, local recurrence-free survival, distant recurrence-free survival and toxicities. | 3 years |
| To correlate efficacy parameters with a) EGFR and downstream pathway activation, b) FcyR polymorphisms, and c) serum cytokine profiles. | 3 years |
| To collect tumor tissue from pretreatment biopsies for cytokine/chemokine and immune biomarker studies on tumor tissue. | 3 years |
Countries
United States
Outcome results
None listed