Use of Pharmacogenetics to Select Erbitux or Cisplatin to Treat Head and Neck Cancer

NCT01790516 | Terminated Results DMC

• 1 other identifier: 2010-439
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This study is for patients with newly diagnosed head and neck cancer that cannot be removed by surgery. The purpose of this study is to determine the feasibility of using genetic variations in patients to select the right drug to treat head and neck cancer. Cisplatin and cetuximab (Erbitux)are both approved by the FDA to treat head and neck cancer in combination with radiation therapy. In this study the investigators will test whether genetic differences between patients can be used to pick which of these two drugs a patient should receive. All patients will have a blood sample drawn that will be tested for genetic differences. If patients have genetic differences that correlate with a better outcome from cisplatin they will receive cisplatin with radiation. If patients have genetic differences that do not correlate with a better outcome from cisplatin they will receive cetuximab with their radiation therapy.

Conditions

Head and Neck Squamous Cell Cancer

Keywords

Head and neck cancer; genetic testing; cisplatin; erbitux; radiation therapy

Outcome Measures

Primary Outcomes (1)

• Feasibility of Returning Genetic Testing Results in a Timely Manner to the Treating Physician

  Feasibility is defined as follows: \- Patients' genetic test results are returned to the treating physician within 3 days

  20 months

Study Arms (2)

Cisplatin

EXPERIMENTAL

Cisplatin

Drug: Cisplatin; Radiation: Radiation

Cetuximab

EXPERIMENTAL

cetuximab

Drug: cetuximab; Radiation: Radiation

Interventions

Cisplatin DRUG

Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy

Also known as: Cispaltin, Platinum

Cisplatin

cetuximab DRUG

Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation.

Also known as: Erbitux

Cetuximab

Radiation RADIATION

daily radiation for 7 weeks

Cetuximab; Cisplatin

Eligibility Criteria

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

You may qualify if:

• Biopsy proven squamous cell carcinoma of the head and neck, including the oral cavity, oropharynx, hypopharynx, or larynx, but not including primary tumors of the nasopharynx, sinuses, or salivary glands.
• Locally advanced, Stage III to IVB disease, and a candidate for primary therapy using chemotherapy and radiation therapy with curative intent.
• Patients with a diagnosis of 'unknown primary' will be eligible if chemoradiotherapy is the primary modality of treatment
• No previous chemotherapy, radiation, or surgery for their diagnosis of head and neck cancer
• Eastern Cooperative Oncology Group performance status \</= 1
• Women of child-bearing potential must have a negative pregnancy test within 30 hours before initiation of study drug dosing. Female subjects of reproductive potential must agree to avoid pregnancy throughout the study and for up to 3 months following discontinuation of study drug. Male subjects must agree to avoid conceiving a child throughout the study and for up to 3 months following discontinuation of study drug;
• Hemoglobin \>/= 8.0 gm/dL
• Absolute neutrophil count \>/= 1500
• Platelet count \>/= 100,000
• Glomerular Filtration Rate \> 50 mL/min calculated by the Cockcroft-Gault equation
• Total bilirubin \</= 2.0 times the upper limit of normal unless the patient has Gilbert's syndrome
• Aspartate aminotransferase and Alanine Aminotransferase \</= 2.5 times the upper limit of normal
• No other current malignancy, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular in situ of the breast. Patients with other malignancies are eligible if they have been continuously disease-free for \>/= 3 years prior to screening for this protocol.
• Age of 18 or older
• Ability and willingness to give informed consent

You may not qualify if:

• Acute treatment for an infection or other serious medical illness within 14 days prior to study entry
• Major surgery within 3 weeks prior to study entry
• Known hypersensitivity to cisplatin or cetuximab
• Patients who have any severe or uncontrolled medical conditions or other conditions that could affect their participation in this study, including: unstable angina, serious uncontrolled cardiac arrhythmia, active acute or uncontrolled infectious disorder, or myocardial infarction \</= 6 months prior to study entry.
• Female patients who are pregnant or breast feeding, or adults who are of reproductive potential and are unwilling to refrain from conceiving a child during study treatment.
• Patients unwilling to comply with the protocol, or provide informed consent
• Psychiatric illness that would limit compliance with study requirements

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown Lombardi Comprhensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Cisplatin; Platinum; Cetuximab; Radiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Metals, Heavy; Elements; Transition Elements; Metals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Physical Phenomena

Results Point of Contact

• Title: Dr John Deeken, PI
• Organization: Inova Health Care System

john.deeken@inova.org

703 776 8161

Study Officials

• John F Deeken, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2012
• First Posted: February 13, 2013
• Study Start: May 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 2, 2014
• Results First Posted: October 2, 2014

Record last verified: 2013-10

Locations

US (1)