Neoplasms

All Conditions

Mouth and Tooth Diseases

Rare Diseases

Adenoma

Salivary Gland Neoplasms

Adenoma, Pleomorphic

Syringoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Mouth Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Salivary Gland Diseases

Neoplasms, Adnexal and Skin Appendage

Oral Cancer

Antineoplastic Agents

All Drugs and Chemicals

Panitumumab

Antineoplastic Agents, Immunological

Panitumumab 2.5 mg/Kg IV, weekly during radiation (total of 6-8 doses).

Radiation 64-70Gy (2.0 Gy/day, 5 days/week)

Radiation

2.5 mg/Kg IV, weekly during RT. 6-7 weeks

Michael K. Gibson, MD

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).

Trial of Radiotherapy and Panitumumab in Salivary Gland Malignancies

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

Amgen

University of Pittsburgh

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).

Postoperative Radiotherapy and Panitumumab

Athanassios Argiris, MD

Standard therapy for high-risk or locally advanced salivary gland malignancies is surgery followed by postoperative radiation therapy. Studies have shown the superiority of combined modality therapy compared to surgery alone. 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 hypothesize that the addition of panitumumab to standard radiotherapy in locally advanced salivary gland malignancies will improve recurrence-free survival (RFS).

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.

Postoperative Radiotherapy and Panitumumab in High-Risk Salivary Gland Malignancies

Phase II Trial of Postoperative Radiotherapy and Panitumumab in High-Risk Salivary Gland Malignancies

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.

Overall survival will be measure via RECIST criteria and analyzed using the Kaplan-Meier method.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial of Radiotherapy and Panitumumab in Salivary Gland Malignancies	NCT00984217	Adenoma, Pleomo... Mixed Salivary ... Salivary Gland ... Syringoma, Chon...	Radiation Panitumumab	18 Years -	University of Pittsburgh
Postoperative Radiotherapy and Panitumumab in High-Risk Salivary Gland Malignancies	NCT01634880	Salivary Gland ...	Postoperative R...	18 Years -	The University of Texas Health Science Center at San Antonio
Postoperative Radiotherapy and Panitumumab in High-Risk Salivary Gland Malignancies	NCT01634880	Salivary Gland ...	Postoperative R...	18 Years -	The University of Texas Health Science Center at San Antonio
Postoperative Radiotherapy and Panitumumab in High-Risk Salivary Gland Malignancies	NCT01634880	Salivary Gland ...	Postoperative R...	18 Years -	The University of Texas Health Science Center at San Antonio

Spots Global Cancer Trial Database for salivary gland malignancies