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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

Primary Purpose

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

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Intraarterial Cetxuimab (Erbitux)

About this trial

This is an interventional treatment trial for Carcinoma, Squamous Cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female patients of ≥18 years of age.
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
Tumor Recurrence which is surgically unresectable
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.
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
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.
Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5X the IUNL.
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.
Patients must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening.
Patients who refuse surgery.

Exclusion Criteria:

Women who are pregnant or lactating.
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.
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.
Pre-existing cardiac or respiratory disorders
Unrelated malignancy within 3 years
History of hypersensitivity reactions to other EGFR inhibitors
Metastatic disease
Less than 6 months from prior Radiation Therapy (Arm 1)
Previous exposure to Cetuximab

Sites / Locations

Lenox Hill Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cetuximab with Radiation Therapy

Cetuximab Alone

Arm Description

For 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.

For 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.

Outcomes

Primary Outcome Measures

The maximum tolerated dose (MTD) of superselective intraarterial Cetuximab.

Descriptive frequency of subjects experiencing toxicities.

Secondary Outcome Measures

Full Information

NCT ID

NCT02438995

First Posted

May 6, 2015

Last Updated

October 27, 2021

Sponsor

Northwell Health

1. Study Identification

Unique Protocol Identification Number

NCT02438995

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Terminated

Why Stopped

Low enrollment

Study Start Date

May 2015 (Actual)

Primary Completion Date

June 2021 (Actual)

Study Completion Date

June 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwell Health

4. Oversight

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cetuximab with Radiation Therapy

Arm Type

Experimental

Arm Description

Arm Title

Cetuximab Alone

Arm Type

Experimental

Arm Description

For 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.

Intervention Type

Drug

Intervention Name(s)

Intraarterial Cetxuimab (Erbitux)

Intervention Description

Super-Selective Intraarterial Infusion of Cetuximab (Erbitux)

Primary Outcome Measure Information:

Title

The maximum tolerated dose (MTD) of superselective intraarterial Cetuximab.

Time Frame

30 days

Title

Descriptive frequency of subjects experiencing toxicities.

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female patients of ≥18 years of age. 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 Tumor Recurrence which is surgically unresectable 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. 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 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. Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5X the IUNL. 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. Patients must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening. Patients who refuse surgery. Exclusion Criteria: Women who are pregnant or lactating. 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. 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. Pre-existing cardiac or respiratory disorders Unrelated malignancy within 3 years History of hypersensitivity reactions to other EGFR inhibitors Metastatic disease Less than 6 months from prior Radiation Therapy (Arm 1) Previous exposure to Cetuximab

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Boockvar, MD

Organizational Affiliation

Northwell Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lenox Hill Hospital

City

New York

State/Province

New York

ZIP/Postal Code

10028

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

27849340

Citation

Tham T, White TG, Chakraborty S, Lall RR, Ortiz R, Langer DJ, Shatzkes D, Filippi CG, Kraus D, Boockvar JA, Costantino PD. Intra-arterial cetuximab for the treatment of recurrent unresectable head and neck squamous cell carcinomadagger. J Exp Ther Oncol. 2016 Nov;11(4):293-301.

Results Reference

derived

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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

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