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

Primary Purpose

Head and Neck Squamous Cell Cancer

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cisplatin

cetuximab

Radiation

About this trial

This is an interventional treatment trial for Head and Neck Squamous Cell Cancer focused on measuring Head and neck cancer, genetic testing, cisplatin, erbitux, radiation therapy

Eligibility Criteria

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

Inclusion Criteria:

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
Subjects must in the opinion of the Investigator be capable of complying with this protocol.

Exclusion Criteria:

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

Sites / Locations

Georgetown Lombardi Comprhensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cisplatin

Cetuximab

Arm Description

Cisplatin

cetuximab

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01790516

First Posted

June 21, 2012

Last Updated

September 26, 2014

Sponsor

Georgetown University

1. Study Identification

Unique Protocol Identification Number

NCT01790516

Brief Title

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

Official Title

A Pilot Prospective Clinical Trial to Use Pharmacogenetics (PGx) to Select Erbitux or Cisplatin to Treat Head and Neck Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Terminated

Why Stopped

low accruals--2 patients were enrolled in over a year

Study Start Date

May 2012 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Georgetown University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Treatment-naive patients with locally advanced, non-metastatic (Stage III to IVB) squamous cell carcinoma of the head and neck who are candidates for concurrent chemoradiotherapy as primary therapy with curative intent will be enrolled. Patients will be genotyped for germline variations at four SNP loci in three genes involved in DNA nucleotide excision repair (ERCC1, ERCC2, and XRCC1). Patients with 3 to 8 variants will receive cisplatin (Arm A). Patients with 2 or fewer variants will receive cetuximab (Arm B). The hypothesis of the study is that prospectively testing patients for variations in DNA repair enzymes to determine whether to use cisplatin or cetuximab in locally advanced head and neck squamous cell cancer is feasible.

6. Conditions and Keywords

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

Head and Neck Squamous Cell Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cisplatin

Arm Type

Experimental

Arm Description

Cisplatin

Arm Title

Cetuximab

Arm Type

Experimental

Arm Description

cetuximab

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

Cispaltin, Platinum

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

cetuximab

Other Intervention Name(s)

Erbitux

Intervention Description

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.

Intervention Type

Radiation

Intervention Name(s)

Radiation

Intervention Description

daily radiation for 7 weeks

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

20 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Subjects must in the opinion of the Investigator be capable of complying with this protocol. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John F Deeken, MD

Organizational Affiliation

Georgetown University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Georgetown Lombardi Comprhensive Cancer Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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