Clinical Trials /

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)

NCT02057107

Description:

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).

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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)
  • 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)

Clinical Trial IDs

  • ORG STUDY ID: 11-112
  • NCT ID: NCT02057107

Conditions

  • Recurrent
  • Head and Neck Cancer

Interventions

DrugSynonymsArms
CetuximabErbituxSBRT + Cetuximab + Docetaxel followed by Cetuximab + Docetaxel
DocetaxelTaxotereSBRT + Cetuximab + Docetaxel followed by Cetuximab + Docetaxel

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
SBRT + Cetuximab + Docetaxel followed by Cetuximab + DocetaxelOtherPreviously Treated With Cetuximab - Group A No Previous Cetuximab - Group C
  • Cetuximab
  • Docetaxel
SBRT + Cetuximab followed by CetuximabOtherPreviously Treated with Cetuximab - Group B No Previous Cetuximab - Group D
  • Cetuximab

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Locoregional progression-free survival (PFS) of previously-irradiated patients with SCCHN treated with SBRT, cetuximab, and docetaxel
Time Frame:1 Year
Safety Issue:
Description:Evaluated by PET/CT or CT

Secondary Outcome Measures

Measure:Acute and late toxicities associated with the above therapy
Time Frame:3 years
Safety Issue:
Description:Determined by patient follow up CTCAE criteria

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Pittsburgh

Last Updated

October 24, 2016