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Stereotactic Body Radiation Therapy (SBRT) With Cetuximab +/- Docetaxel Followed by Adjuvant Cetuximab +/- Docetaxel in Recurrent, Previously-Irradiated Squamous Cell Carcinoma of the Head and Neck (SCCHN)

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ClinicalTrials.gov Identifier: NCT02057107
Recruitment Status : Recruiting
First Posted : February 6, 2014
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
David A. Clump, MD, PhD, University of Pittsburgh

Brief Summary:
Compare the overall survival of patients with the addition of docetaxel to the overall survival of patients treated with SBRT and cetuximab alone. In addition, we will determine the difference in progression free survival (PFS), the rate of local recurrence (LR) and of distant metastases (DM) across the SBRT and cetuximab + docetaxel arm and the arm receiving SBRT and cetuximab alone. To better resolve the impact of the experimental treatment on PFS, LR, and DM, patients will be stratified by the presence/absence of prior cetuximab treatment and then randomized to either the control arm (cetuximab and SBRT only) or the experimental arm (cetuximab, SBRT, and docetaxel).

Condition or disease Intervention/treatment Phase
Recurrent Head and Neck Cancer Radiation: SBRT Drug: Cetuximab Drug: Docetaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Stereotactic Body Radiation Therapy (SBRT) With Cetuximab +/- Docetaxel Followed by Adjuvant Cetuximab +/- Docetaxel in Recurrent, Previously-Irradiated Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Study Start Date : May 2013
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
SBRT + Cetuximab + Docetaxel followed by Cetuximab + Docetaxel
Previously Treated With Cetuximab - Group A No Previous Cetuximab - Group C
Radiation: SBRT
8.8-10 Gy per fraction (total: 44-50 Gy)
Other Names:
  • Radiosurgery
  • Stereotactic radiosurgery
  • CyberKnife
  • True Beam
  • Trilogy

Drug: Cetuximab

Day -7 (One week prior to commencement of stereotactic radiosurgery):

Cetuximab, 400 mg/m2

Days 0 and 8 (The 1st and 2nd week of radiosurgery):

Cetuximab, 250 mg/m2 Cetuximab, 250 mg/m2 will be given weekly ( following radiosurgery)

Other Name: Erbitux

Drug: Docetaxel
Days 0 and 8 (The 1st and 2nd week of radiosurgery) Docetaxel, 25 mg/m2 Docetaxel, 25 mg/m2 will be given weekly (following radiosurgery)
Other Name: Taxotere

SBRT + Cetuximab followed by Cetuximab
Previously Treated with Cetuximab - Group B No Previous Cetuximab - Group D
Radiation: SBRT
8.8-10 Gy per fraction (total: 44-50 Gy)
Other Names:
  • Radiosurgery
  • Stereotactic radiosurgery
  • CyberKnife
  • True Beam
  • Trilogy

Drug: Cetuximab

Day -7 (One week prior to commencement of stereotactic radiosurgery):

Cetuximab, 400 mg/m2

Days 0 and 8 (The 1st and 2nd week of radiosurgery):

Cetuximab, 250 mg/m2 Cetuximab, 250 mg/m2 will be given weekly ( following radiosurgery)

Other Name: Erbitux




Primary Outcome Measures :
  1. Locoregional progression-free survival (PFS) of previously-irradiated patients with SCCHN treated with SBRT, cetuximab, and docetaxel [ Time Frame: 1 Year ]
    Evaluated by PET/CT or CT


Secondary Outcome Measures :
  1. Acute and late toxicities associated with the above therapy [ Time Frame: 3 years ]
    Determined by patient follow up CTCAE criteria



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 50 Gy.
  • Disease confined to locoregional site and can be encompassed in a stereotactic body 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.
  • Karnofsky performance status > 60 (ECOG 0-1)
  • 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
  • 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
  • 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, docetaxel or similar agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057107


Contacts
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Contact: Karen D Holeva, BS 412-623-1275 holevakd@upmc.edu
Contact: Dwight E Heron, MD 412-623-6720 herond2@upmc.edu

Locations
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United States, Pennsylvania
UPMC Shadyside Radiation Oncology Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Karen D Holeva, BS    412-623-1275    holevakd@upmc.edu   
Contact: Dwight E Heron, MD    412-623-6720    herond2@upmc.edu   
Sub-Investigator: David A Clump, MD, PhD         
Sub-Investigator: Steven Burton, MD         
Sub-Investigator: Brian J Karlovits, DO         
Sub-Investigator: Robert Ferris, MD         
Sub-Investigator: James Ohr, DO         
Sub-Investigator: Julie Bauman, MD         
Principal Investigator: Dwight E Heron, MD         
Sponsors and Collaborators
David A. Clump, MD, PhD
Investigators
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Principal Investigator: Dwight E Heron, MD University of Pittsburgh
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Responsible Party: David A. Clump, MD, PhD, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02057107    
Other Study ID Numbers: 11-112
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Docetaxel
Cetuximab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological