Preoperative Treatment With Cetuximab and/or IMC-A12

NCT00957853 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 2008-0342NCI-2011-03039
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to give cetuximab and/or IMC-A12 before surgery for squamous cell carcinoma of the head and neck, in order to learn if these study drugs may cause changes in biomarkers. Biomarkers are chemical "markers" in the blood and/or tissue that may be related to a reaction to study treatment. The safety of the study treatments will also be studied.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Head and Neck Cancer; Squamous cell carcinoma of the head and neck; HNSCC; Cetuximab; IMC-A12; Tumor; Biomarkers; Phospho-AKT; Surgical resection

Outcome Measures

Primary Outcomes (1)

• AKT Modulation

  An IHC scoring system used to quantify phospho-Akt levels based on staining intensity x extension. Staining intensity graded as undetectable (0), weak (1), medium (2), or strong (3). Staining extension graded as percentage of positive cells per high power field at x20 magnification. Final score will therefore range from 0 to 300. Modulation of phospho-Akt (difference in IHC score between the surgical specimen and the baseline biopsy) and other biomarkers compared between any two of the three treatment arms with the use of the Wilcoxon rank sum test. Type I error of alpha=0.05 (two-sided test) used. Correlation between biomarkers and molecular response or toxicity performed in an exploratory fashion.

  Biopsy at baseline and surgery (surgery should be within 10 days of last treatment)

Secondary Outcomes (1)

• Number of Participants With Objective Response

  up to 4 months post treatment start

Study Arms (3)

Group 1: Cetuximab

EXPERIMENTAL

Cetuximab: 400 mg/m2 i.v. over 120 minutes on week 1, and 250 mg/m2 on week 2 and 3 i.v. over 60 minutes

Drug: Cetuximab; Procedure: Surgical tumor resection

Group 2: IMC-A12

EXPERIMENTAL

IMC-A12: 6 mg/kg/week i.v. over 1 hour on weeks 1 and 2 and 3.

Drug: IMC-A12; Procedure: Surgical tumor resection

Group 3: Cetuximab + IMC-A12

EXPERIMENTAL

Cetuximab: 400 mg/m2 i.v. over 120 minutes on week 1, and 250 mg/m2 on week 2 and 3 i.v. over 60 minutes. IMC-A12: 6 mg/kg/week i.v. over 1 hour on weeks 1 and 2 and 3.

Drug: Cetuximab; Drug: IMC-A12; Procedure: Surgical tumor resection

Interventions

Cetuximab DRUG

First dose of 400 mg/m\^2 by vein on Days 1 and 8 over 2 hours, second dose of 250 mg/m\^2 on week 2 and 3 (if applicable) given over 1 hour.

Also known as: C225, Erbitux, IMC-C225

Group 1: Cetuximab; Group 3: Cetuximab + IMC-A12

IMC-A12 DRUG

6 mg/kg/week by vein on Days 1 and 8 over 1 hour on weeks 1 and 2 and 3 (if applicable).

Group 2: IMC-A12; Group 3: Cetuximab + IMC-A12

Surgical tumor resection PROCEDURE

Surgical tumor resection on Day 10.

Group 1: Cetuximab; Group 2: IMC-A12; Group 3: Cetuximab + IMC-A12

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically-confirmed diagnosis of squamous cell carcinoma of the head and neck (excluding carcinomas of the nasopharynx types II and III according to the World Health Organization criteria), for whom surgical resection of the tumor is planned as part of the treatment. Patients with skin squamous cell carcinomas of the head and neck region will also be included in this study.
• There is availability of a baseline, paraffin-embedded, tumor specimen for biomarker evaluation. No anti-neoplastic treatment is allowed between the time from obtaining the baseline tumor specimen and randomization. If a baseline tumor specimen is not available, a biopsy of the tumor will be performed prior to randomization.
• Prior treatment with biological agents targeted to the epidermal growth factor receptor is allowed, provided the time from last exposure to this treatment was \>/= 6 months.
• The patient has a fasting serum glucose \< 130 mg/dL and HbA1C \< 7.0%. Patients with a history of diabetes mellitus are allowed to participate, provided that they are on a stable dietary or therapeutic regimen for this condition.
• The patient has adequate renal function, defined by serum creatinine \</= 1.5 x the institutional upper limit of normal (ULN), or creatinine clearance \>/=60 mL/min for patients with creatinine levels above the ULN.
• Because the teratogenicity of cetuximab and IMC-A12 is not known, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
• The patient is age \>/= 18 years.
• The patient or the patient's legally authorized representative has the ability to understand and the willingness to sign a written informed consent document.
• ECOG performance status of 0-2.

You may not qualify if:

• Patients receiving any other agent (investigational or not) with potential anti-neoplastic activity within 3 weeks prior to obtaining the baseline tumor specimen for biomarker evaluation.
• Patients receiving concomitant radiation.
• Prior treatment with an agent targeted at the insulin-like growth factor-1 receptor.
• History of allergic reactions attributed to compounds of chemical and biological composition similar to those of cetuximab or IMC-A12.
• Pregnant patients, or patients who are breast feeding (patients who have a positive pregnancy test within the first 30 days before the first dose of treatment are excluded).
• Patients with uncontrolled illnesses which, in the opinion of the investigator, could be aggravated by the administration of the study drug(s).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms; Neoplasms

Interventions

Cetuximab; cixutumumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms by Site

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. Maura Gillison, PHD/Professor, Thoracic-Head & Neck Med Onc
• Organization: UT MD Anderson Cancer Center

mgillison@mdanderson.org

713-792-6363

Study Officials

• Maura Gillison, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2009
• First Posted: August 13, 2009
• Study Start: October 17, 2011
• Primary Completion: August 15, 2018
• Study Completion: August 15, 2018
• Last Updated: March 19, 2020
• Results First Posted: March 19, 2020

Record last verified: 2020-03

Locations

US (1)