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| Sponsor: | University of Pittsburgh |
|---|---|
| Collaborator: |
Amgen |
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00984217 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Adenoma, Pleomorphic Mixed Salivary Gland Tumor Salivary Gland Tumor, Mixed Syringoma, Chondroid |
Radiation: Radiation Drug: Panitumumab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Postoperative Radiotherapy and Panitumumab in High-risk Salivary Gland Malignancies |
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | November 2015 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Panitumumab
Panitumumab 2.5 mg/Kg IV, weekly during radiation (total of 6-8 doses).
|
Radiation: Radiation
Radiation 64-70Gy (2.0 Gy/day, 5 days/week)
Drug: Panitumumab
2.5 mg/Kg IV, weekly during RT. 6-7 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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:
Patients must have normal organ and marrow function as defined below:
Exclusion Criteria:
Pregnant women are excluded from this study because chemotherapy and radiation therapy have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with chemotherapy, breastfeeding should be discontinued if the mother is treated with chemotherapy. Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.
Contacts and Locations| United States, Ohio | |
| UPMC Cancer Center - Teramana Cancer Center - Steubenville | |
| Steubenville, Ohio, United States, 43952 | |
| United States, Pennsylvania | |
| UPMC Cancer Center - Beaver | |
| Beaver, Pennsylvania, United States, 15009 | |
| UPMC Cancer Center - Clairton | |
| Clairton, Pennsylvania, United States, 15025 | |
| UPMC Cancer Center -Arnold Palmer Pavilion | |
| Greensburg, Pennsylvania, United States, 15601 | |
| UPMC Cancer Center - Oakbrook Commons | |
| Greensburg, Pennsylvania, United States, 15601 | |
| UPMC Cancer Center - Arnold Palmer Pavilion - Greensburg | |
| Greensburg, Pennsylvania, United States, 15601 | |
| UPMC Cancer Center - Oakbrook Commons - Greensburg | |
| Greensburg, Pennsylvania, United States, 15601 | |
| UPMC Cancer Center - Indiana | |
| Indiana, Pennsylvania, United States, 15701 | |
| UPMC Cancer Center - John P. Murtha Pavilion - Johnstown | |
| Johnstown, Pennsylvania, United States, 15901 | |
| UPMC Cancer Center - McKeesport | |
| McKeesport, Pennsylvania, United States, 15132 | |
| UPMC Cancer Center - Monroeville | |
| Monroeville, Pennsylvania, United States, 15146 | |
| UPMC Cancer Center - Sewickley Medical Oncology/Hematology Group | |
| Moon Township, Pennsylvania, United States, 15108 | |
| UPMC Cancer Center -Mt. Pleasant | |
| Mt. Pleasant, Pennsylvania, United States, 15666 | |
| UPMC Cancer Center - New Castle | |
| New Castle, Pennsylvania, United States, 16105 | |
| UPMC Cancer Center - Passavant | |
| Pittsburgh, Pennsylvania, United States, 15237 | |
| UPMC Presbyterian -Radiation Oncology | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Hillman Cancer Center: University of Pittsburgh Cancer Institute / UPMC Department of Radiology | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| UPMC Cancer Center - St. Margaret's | |
| Pittsburgh, Pennsylvania, United States, 15215 | |
| UPMC Cancer Center - Upper St. Clair | |
| Pittsburgh, Pennsylvania, United States, 15241 | |
| UPMC Cancer Centers | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| UPMC Cancer Center -Delafield Rd. | |
| Pittsburgh, Pennsylvania, United States, 15215 | |
| UPMC Cancer Center -Drake | |
| Pittsburgh, Pennsylvania, United States, 15241 | |
| UPMC Cancer Center -UPMC Shadyside | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| UPMC Cancer Center -UPMC Northwest | |
| Seneca, Pennsylvania, United States, 16346 | |
| UPMC Cancer Center - Uniontown | |
| Uniontown, Pennsylvania, United States, 15401 | |
| UPMC Cancer Center - Washington | |
| Washington, Pennsylvania, United States, 15301 | |
| UPMC Cancer Center - North Hills | |
| Wexford, Pennsylvania, United States, 15090 | |
| Principal Investigator: | Michael K. Gibson, MD | University of Pittsburgh |
More Information
| Responsible Party: | Michael K. Gibson, MD, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00984217 History of Changes |
| Other Study ID Numbers: | 08-112 |
| Study First Received: | September 23, 2009 |
| Last Updated: | June 12, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
panitumumab salivary gland malignancies radiotherapy |
|
Adenoma Neoplasms Adenoma, Pleomorphic Salivary Gland Neoplasms Syringoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Complex and Mixed Mouth Neoplasms Head and Neck Neoplasms |
Neoplasms by Site Mouth Diseases Stomatognathic Diseases Salivary Gland Diseases Adenoma, Sweat Gland Neoplasms, Adnexal and Skin Appendage Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |