Re-irradiation With Fractionated Stereotactic Radiosurgery Plus Cetuximab in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01104922
First received: April 8, 2010
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

The primary objectives of this study are to determine the 1-year progression-free survival (PFS) of previously irradiated patients with squamous cell carcinoma of the head and neck (SCCHN) treated with radiosurgery and cetuximab and to evaluate the acute and late toxicities associated with the above therapy.


Condition Intervention Phase
Squamous Cell Carcinoma of the Head and Neck
Other: Cetuximab and stereotactic radiosurgery
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Re-irradiation With Fractionated Stereotactic Radiosurgery Plus Cetuximab in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • To determine the 1-year progression-free survival (PFS) of previously irradiated patients with SCCHN treated with radiosurgery and cetuximab; [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy); - Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment


Secondary Outcome Measures:
  • To evaluate the acute and late toxicities associated with the above therapy. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    To determine the objective response rate, PFS and overall survival (OS) and to evaluate changes in tumor glucose metabolism post-therapy as assessed by FDG PET Evaluate changes in tumor hypoxia as a result of SRS through assessment by pre-and post-treatment FMISO PET. To determine prognostic factors that may predict the likelihood of locoregional control in patients with recurrent disease treated with radiosurgery and to evaluate the expression of specific biomarkers in tumor before and after treatment and the impact of radiosurgery on the QOL of patients treated for recurrent SCCHN.


Estimated Enrollment: 59
Study Start Date: July 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Cetuximab and stereotactic radiosurgery
    Treatments Administered: - Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy); - Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: * Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) * Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Administration of cetuximab may or not be the same day that a fraction of SRS is given. Infusion reactions may occurring during the administration of cetuximab and rarely post-infusion.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven recurrent squamous cell carcinoma of the head and neck (SCCHN), who has received prior radiotherapy with or without chemotherapy. New primary is allowed if location is in a previously irradiated field. Biopsy is recommended for each recurrence; but is not mandated per study. This will be at the discretion of the principal investigator.
  • Prior radiation dose of at least 60 Gy.
  • Disease confined to locoregional site and can be encompassed in a stereotactic radiosurgery "portal"
  • Tumor must be deemed to be inoperable or unresectable either by clinical or radiographic criteria. These criteria include encasement of great vessels, vertebral invasion or undue peri-operative risk.
  • Prior surgery for recurrent or new SCCHN is allowed in previously irradiated patients. A minimum of 4 weeks should elapse between any surgery and treatment on study. However, high risk pathologic features should be present, such as positive margins, positive lymphadenopathy, perineural or angiolymphatic invasion. Measurable disease must be present for assessment of response.
  • Karnofsky performance status > 60 (ECOG 0-2)
  • Prior treatment with an EGFR Inhibitor is allowed if it was a part of prior curative therapy and was completed at least 30 days prior to commencement of study therapy
  • Any number of prior chemotherapy regimens are allowed
  • Measurable disease on imaging studies (MRI, CT, PET-CT or physical exam)
  • Age > 18
  • Estimated life expectancy > 12 weeks
  • No prior radiation therapy or chemotherapy within 1 month of study enrollment
  • No prior chemotherapy or targeted therapy within the previous 4 weeks
  • ANC > 1000, PLT>75,000, Serum creatinine<2.5 mg/dL, Bilirubin <1.5 x upper limits of normal (ULN)
  • Diabetes must be controlled prior to PET-CT scanning (blood glucose <200 mg/dL)
  • Ability to provide written informed consent

Exclusion Criteria:

  • Evidence of distant metastasis on upright chest x-ray (CXR), computed tomography (CT) or other staging studies
  • History of any cancer other than SCCHN (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last 5 years.
  • Patients in their reproductive age group should use an effective method of birth control. Patients who are breast-feeding, or have a positive pregnancy test will be excluded from the study
  • Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator
  • Concurrent serious infection
  • History of known hypersensitivity to cetuximab or similar agents
  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: NCT01104922

Contacts
Contact: Dwight Heron, MD 412-623-6723 herond2@upmc.edu
Contact: Karen Holeva, BS 412-623-1276 holevakd@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Cancer Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Dwight Heron, MD    412-641-4600    herond2@upmc.edu   
Principal Investigator: Dwight Heron, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Dwight Heron, FACP, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01104922     History of Changes
Other Study ID Numbers: UPCI 06-093
Study First Received: April 8, 2010
Last Updated: December 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Re-irradiation with Fractionated Stereotactic Radiosurgery for Head and Neck

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Cetuximab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014