Cetuximab Before Surgery in Treating Patients With Aggressive Locally Advanced Skin Cancer

NCT02324608 | Completed Results

• 4 other identifiers: 091303NCI-2014-02027Pro20140000555P30CA072720
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies the side effects and how well cetuximab before surgery works in treating patients with skin cancer that forms, grows, and spreads quickly and has spread from where it started to nearby tissue or lymph nodes. Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways be targeting certain cells. Giving cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Conditions

Recurrent Skin Cancer; Squamous Cell Carcinoma of the Skin

Outcome Measures

Primary Outcomes (1)

• Response Rate of Cetuximab by RECIST Criteria

  A one-sided Binomial exact test will be used.

  Up to 2 years

Secondary Outcomes (4)

• Progression-free Survival

  Up to 2 years

• Overall Survival

  Up to 2 years

• Downstream Activation of Signaling Pathways Without a Known Driver, Including the EGFRpathway

  Up to 2 years

• Potential Markers of Response and/or Resistance to Cetuximab Therapy

  Up to 2 years

Study Arms (1)

Treatment (cetuximab)

EXPERIMENTAL

Patients receive cetuximab IV over 60-120 minutes once weekly for 8 weeks.

Biological: cetuximab; Other: laboratory biomarker analysis

Interventions

cetuximab BIOLOGICAL

Given IV

Also known as: C225, C225 monoclonal antibody, IMC-C225, MOAB C225, monoclonal antibody C225

Treatment (cetuximab)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (cetuximab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have untreated or relapsed SCCS that is considered to be aggressive and locally advanced by the following criteria: tumors 2 cm or more, tumors invading deep tissues such as muscle, cartilage or bone; tumors showing perineural invasion, and/or tumors metastatic to loco-regional lymph nodes; patients may have had prior surgical interventions or been treated with investigational agents with residual or recurrent disease
• Patients must give informed consent
• Patients must agree to pre- and post-treatment biopsies
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
• Estimated life expectancy of at least 12 weeks
• Negative pregnancy test

You may not qualify if:

• Second primary malignancy only if treatment would interfere with the patient's participation in this trial in the opinion of the treating physician; clear exceptions are 1) patient had a second primary malignancy but has been treated and disease free for at least 3 years, 2) in situ carcinoma (e.g. in situ carcinoma of the cervix) and, 3) additional skin cancers that have been definitively treated by surgery and/or radiation; patients with chronic lymphocytic leukemia will be allowed if their blood counts are within acceptable hematologic parameters and if they are not currently requiring cytotoxic or biologic anticancer treatment (supportive treatment such as intravenous immunoglobulin \[IVIG\] is permitted)
• Patients with distant organ metastases will not be included in this study
• Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to cetuximab or other agents used in the study
• Women who are pregnant; women of childbearing age must agree to undergo a pregnancy test prior to therapy and to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 6 months after; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Serum calcium (ionized or adjusted for albumin) \< 8 mg/dl (1.75 mmol/L) or \> 12.5 mg/dl (\> 3.1 mmol/L) despite intervention to normalize levels
• Magnesium \< 1.4 mg/dl (\< 0.4 mmol/L) or \> 3 mg/dl (\> 1.23 mmol/L) despite intervention to normalize levels
• Potassium \< 3.5 mmol/L or \> 6 mmol/L despite intervention to normalize levels

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator
• Rutgers Cancer Institute of New Jersey: collaborator

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Adam Berger
• Organization: Cancer Institute of New Jersey Rutgers

ab2047@cinj.rutger

732-235-8675

Study Officials

• Adam Berger, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: December 24, 2014
• Study Start: January 30, 2015
• Primary Completion: December 9, 2020
• Study Completion: May 30, 2023
• Last Updated: December 20, 2023
• Results First Posted: December 20, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)