Study to Evaluate the Effect of Cetuximab on Corrected QT (QTc) Interval Changes in Patients With Advanced Malignancies From Solid Tumors

NCT00698841 | Completed Phase 2 Results

• 1 other identifier: CA225-315
• Study Type: interventional
• Target: 79
• Locations: 2 countries
• Sites: 16

Brief Summary

The purpose of this study is to determine whether corrected QT (QTc) interval changes occur on an electrocardiogram (ECG) when cetuximab is administered to the study population.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Clinically Meaningful Prolongation of the QT Interval Corrected for Heart Rate (QTc) From Time-matched Baseline

  12-Lead continuous digital electrocardiogram (ECG) data were collected at preselected time points at baseline visit and on Days 1, 8, 15, 22, and 29. The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. The corrected QTc is the QT interval corrected for heart rate. Prolongation of the QTc was identified as clinically meaningful at the investigator's discretion.

  Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)

• Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point

  The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. The QTc is the QT interval corrected for heart rate. The QTcF=QT/RR\^1/3, where RR=RR interval in seconds. Baseline=predose. Mean change in QTc interval from baseline to time t=QTc interval at time t minus QTc interval at baseline.

  Predose Day 1 (Baseline) to end of Cycle 1 (28 days)

Secondary Outcomes (6)

• Number of Participants With Clinically Significant Changes in PR Interval, QRS Interval, and Heart Rate

  Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)

• Number of Participants With Death, Treatment-related Death, Serious Adverse Events (SAEs), Treatment-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Treatment-related AEs Leading to Discontinuation

  Baseline through Cycle 1 (28 days), continuously

• Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade

  Baseline through Cycle 1 (28 days), continuously

• Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study

  At screening, at the end of Cycle 1 (28 days)

• Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued)

  At screening, at the end of Cycle 1 (28 days)

Study Arms (1)

Cetuximab

EXPERIMENTAL

Drug: Cetuximab

Interventions

Cetuximab DRUG

Cetuximab administered by intravenous (IV) infusion at an initial dose of 400 mg/m\^2 over 120 minutes on Day 1 followed by a weekly maintenance IV dose of 250 mg/m\^2 over 60 minutes.

Also known as: Erbitux

Cetuximab

Eligibility Criteria

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

You may qualify if:

• Advanced or metastatic malignant disease originating from solid tumors
• Adequate recovery from previous therapy or intervention; at least 21 days since major surgery or prior radiation therapy
• Measurable or evaluable disease

You may not qualify if:

• Women of childbearing potential (WOCBP) who are breastfeeding, pregnant, or unwilling or unable to use acceptable contraception during the study and for at least 12 weeks after the last on-study dose of cetuximab
• Men unwilling to use acceptable contraception during the study if engaged in sexual relations with a WOCBP
• Symptomatic brain metastasis
• History of myocardial infarction 6 months or less prior to study entry, of severe congestive heart failure, of uncontrolled angina, or of uncontrolled arrhythmias
• Clinically relevant abnormality on screening electrocardiogram (ECG), preventing an accurate measurement of the QT interval
• Congenital long QT syndrome
• History of risk factors for ventricular tachycardia or Torsades de pointes or history of fainting, unexplained loss of consciousness, or convulsions
• Prolonged QTc interval on screening ECG (greater than 470 msec) using Fridericia's correction formula
• Heart rate slower than 50 bpm or faster than 100 bpm at rest during screening ECG measurements
• Implantable pacemaker or automatic implantable cardioverter defibrillator
• Sustained supine systolic blood pressure higher than 150 mmHg or lower than 90 mmHg or a diastolic blood pressure lower than 45 mmHg or higher than 95 mmHg at screening
• Known history of arterial thrombotic events within 6 months prior to study initiation
• Known history of significant peripheral artery disease
• Current participation in a clinical trial with another investigational new drug or device
• Receipt of an investigational new drug or device within 21 days prior to enrollment in this study

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (16)

Northwest Alabama Cancer Center

Muscle Shoals, Alabama, 35661, United States

Location

Donald W. Hill, MD

Casa Grande, Arizona, 85222, United States

Location

Compassionate Cancer Care Medical Group, Inc

Corona, California, 92879, United States

Location

Compassionate Cancer Care Medical Group Inc

Fountain Valley, California, 92708, United States

Location

Pacific Shores Medical Group

Long Beach, California, 90813, United States

Location

Desert Hospital Comprehensive Cancer Center

Palm Springs, California, 92262, United States

Location

Compassionate Cancer Care Medical Group, Inc

Riverside, California, 92501, United States

Location

American Institute Research

Whittier, California, 90603, United States

Location

Georgetown University Medical Center

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

Location

Baptist Cancer Institute

Jacksonville, Florida, 32207, United States

Location

Ocala Oncology Center

Ocala, Florida, 34471, United States

Location

Brinz, Burroff, Gurtler, & Russo

Metairie, Louisiana, 70006, United States

Location

Cancer Specialists Of Oklahoma

Oklahoma City, Oklahoma, 73112, United States

Location

Pharma Resource

East Providence, Rhode Island, 02915, United States

Location

Austin Cancer Centers

Austin, Texas, 78759, United States

Location

Local Institution

San Juan, Pr, 00910, Puerto Rico

Location

Related Publications (1)

• Deeken JF, Shimkus B, Liem A, Hill D, Gurtler J, Berghorn E, Townes L, Lu H, Trifan O, Zhang S. Evaluation of the relationship between cetuximab therapy and corrected QT interval changes in patients with advanced malignancies from solid tumors. Cancer Chemother Pharmacol. 2013 Jun;71(6):1473-83. doi: 10.1007/s00280-013-2146-5. Epub 2013 Apr 16.

  PMID: 23589315 DERIVED

Related Links

• Investigator Inquiry form

MeSH Terms

Interventions

Cetuximab

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: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2008
• First Posted: June 17, 2008
• Study Start: February 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: December 24, 2015
• Results First Posted: May 11, 2011

Record last verified: 2015-11

Locations

US (15); PR (1)