Clinical Trials /

Super-Selective Intraarterial Infusion of Cetuximab (Erbitux) With or Without Radiation Therapy for the Treatment of Unresectable Recurrent Squamous Cell Carcinoma of the Head and Neck

NCT02438995

Description:

This is an open-label, non-randomized, two arm, Phase I research study of superselective intraarterial Cetuximab (Erbitux) with or without radiation therapy for treatment of recurrent unresectable squamous cell carcinoma of the head and neck (HNSCC).

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

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Super-Selective Intraarterial Infusion of Cetuximab (Erbitux) With or Without Radiation Therapy for the Treatment of Unresectable Recurrent Squamous Cell Carcinoma of the Head and Neck
  • Official Title: Phase I Trial of Super-Selective Intraarterial Infusion of Cetuximab (Erbitux) With or Without Radiation Therapy for the Treatment of Unresectable Recurrent Squamous Cell Carcinoma of the Head and Neck

Clinical Trial IDs

  • ORG STUDY ID: 15-182
  • NCT ID: NCT02438995

Conditions

  • Carcinoma, Squamous Cell
  • Carcinoma, Squamous Cell of Head and Neck

Interventions

DrugSynonymsArms
Intraarterial Cetxuimab (Erbitux)Cetuximab with Radiation Therapy

Purpose

This is an open-label, non-randomized, two arm, Phase I research study of superselective intraarterial Cetuximab (Erbitux) with or without radiation therapy for treatment of recurrent unresectable squamous cell carcinoma of the head and neck (HNSCC).

Trial Arms

NameTypeDescriptionInterventions
Cetuximab with Radiation TherapyExperimentalFor subjects receiving radiation therapy, the treatment schedule will consist of a re-irradiation dose of approximately 70 Gy over 6-7 weeks. This experimental treatment arm will add IA Cetuximab administration every three weeks up to 2 doses to this radiation schedule.
  • Intraarterial Cetxuimab (Erbitux)
Cetuximab AloneExperimentalFor subjects who are not candidates for re-irradiation, this experimental treatment arm will include only IA Cetuximab administration every three weeks up to 2 doses.
  • Intraarterial Cetxuimab (Erbitux)

Eligibility Criteria

        Inclusion Criteria:

          1. Male or female patients of ≥18 years of age.

          2. Patients with a documented diagnosis of recurrent head and neck squamous cell cancer
             (squamous cell carcinoma, including nasopharyngeal cancer, or adenoid cystic
             carcinoma).

             Patients must have at least one confirmed and evaluable tumor site.* The recurrence
             must have bidimensional measurements by clinical examination or CT/MRI/PET scan. A
             confirmed recurrence site may also be biopsy-proven

          3. Tumor Recurrence which is surgically unresectable

          4. Patients must have a Karnofsky performance status ≥70% (or the equivalent ECOG level
             of 0-2) (see Appendix Performance Status Evaluation) and an expected survival of ≥
             three months.

          5. Patients must have adequate hematologic reserve with WBC≥3000/mm3, absolute
             neutrophils ≥1500/mm3 and platelets ≥100,000/ mm3. Patients who are on Coumadin must
             have a platelet count of ≥150,000/ mm3

          6. Pre-enrollment chemistry parameters must show: bilirubin<1.5X the institutional upper
             limit of normal (IUNL); AST or ALT<2.5X IUNL and creatinine<1.5X IUNL.

          7. Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5X the IUNL.

          8. Patients must agree to use a medically effective method of contraception during and
             for a period of three months after the treatment period. A pregnancy test will be
             performed on each premenopausal female of childbearing potential immediately prior to
             entry into the research study.

          9. Patients must be able to understand and give written informed consent. Informed
             consent must be obtained at the time of patient screening.

         10. Patients who refuse surgery.

        Exclusion Criteria:

          1. Women who are pregnant or lactating.

          2. Women of childbearing potential and fertile men will be informed as to the potential
             risk of procreation while participating in this research trial and will be advised
             that they must use effective contraception during and for a period of three months
             after the treatment period.

          3. Patients with significant intercurrent medical or psychiatric conditions that would
             place them at increased risk or affect their ability to receive or comply with
             treatment or post-treatment clinical monitoring.

          4. Pre-existing cardiac or respiratory disorders

          5. Unrelated malignancy within 3 years

          6. History of hypersensitivity reactions to other EGFR inhibitors

          7. Metastatic disease

          8. Less than 6 months from prior Radiation Therapy (Arm 1)

          9. Previous exposure to Cetuximab
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:The maximum tolerated dose (MTD) of superselective intraarterial Cetuximab.
Time Frame:30 days
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Northwell Health

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