Trial of Radiotherapy and Panitumumab in Salivary Gland Malignancies

This study has been withdrawn prior to enrollment.
(Decided not to pursue at UPCI)
Sponsor:
Collaborator:
Amgen
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00984217
First received: September 23, 2009
Last updated: June 12, 2011
Last verified: June 2011
  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 2

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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the overall survival, local recurrence-free survival, distant recurrence-free survival and toxicities. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • To correlate efficacy parameters with a) EGFR and downstream pathway activation, b) FcyR polymorphisms, and c) serum cytokine profiles. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • To collect tumor tissue from pretreatment biopsies for cytokine/chemokine and immune biomarker studies on tumor tissue. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

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
Criteria

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.

Exclusion Criteria:

  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements.
  • Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction. All patients will have a baseline EKG. If abnormalities consistent with active coronary artery disease are detected, the patient will be referred to a cardiologist for appropriate evaluation and management prior to treatment on study.
  • Patients may not be receiving any other investigational agents.
  • No history of prior malignancy, with the exception of basal carcinoma of the skin or in situ cervical cancer, or malignancy that has been treated with a curative intent with a 3-year disease-free survival.
  • 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.

    • All WOCBP MUST have a negative urine pregnancy test at baseline, or within 7 days prior to receiving investigational product. The minimum sensitivity of the pregnancy test must be 25 IU/L or equivalent units of HCG. If the urine pregnancy test is positive, a serum pregnancy test will then be performed to confirm the result. In the event that both the urine and serum pregnancy tests are positive, the subject must not receive investigational product and must not be enrolled in the study.
    • In addition, all WOCBP should be instructed to contact the Investigator immediately if they suspect they might be pregnant (e.g., missed or late menstrual period) at any time during study participation.
    • The Investigator must immediately notify Amgen in the event of a confirmed pregnancy in a patient participating in the study.
  • Prior severe infusion reaction to a human monoclonal antibody.
  • Prior radiotherapy, chemotherapy or EGFR inhibitor for head and neck cancer.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00984217

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
Sponsors and Collaborators
University of Pittsburgh
Amgen
Investigators
Principal Investigator: Michael K. Gibson, MD University of Pittsburgh
  More Information

No publications provided

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

Keywords provided by University of Pittsburgh:
panitumumab
salivary gland malignancies
radiotherapy

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on August 18, 2014