Clinical trial NCT00698841: Study to Evaluate the Effect of Cetuximab on Corrected QT (QTc) Interval Changes in Patients With Advanced Malignancies From Solid Tumors
Official title: A Study to Evaluate the Relationship Between Cetuximab Therapy and Corrected QT (QTc) Interval Changes in Patients With Advanced Malignancies From Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

* 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

Exclusion criteria:

* 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

Primary outcomes:
measure: Number of Participants With Clinically Meaningful Prolongation of the QT Interval Corrected for Heart Rate (QTc) From Time-matched Baseline
timeFrame: Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)
measure: Mean Change in QTc From Time-matched Baseline Assessed Using Fridericia's Correction Formula (QTcF) by Study Day and Time Point
timeFrame: Predose Day 1 (Baseline) to end of Cycle 1 (28 days)
Secondary outcomes:
measure: Number of Participants With Clinically Significant Changes in PR Interval, QRS Interval, and Heart Rate
timeFrame: Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)
measure: 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
timeFrame: Baseline through Cycle 1 (28 days), continuously
measure: Number of Participants With AEs of Special Interest by Worst Common Terminology Criteria (CTC) Grade
timeFrame: Baseline through Cycle 1 (28 days), continuously
measure: Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study
timeFrame: At screening, at the end of Cycle 1 (28 days)
measure: Number of Participants With Serum Chemistry Abnormalities by Worst CTC Grade at Baseline and On-study (Continued)
timeFrame: At screening, at the end of Cycle 1 (28 days)
measure: Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study
timeFrame: At screening, weekly prior to start of cetuximab infusion, at end of Cycle 1 (28 days), and at 30-day follow-up
Other outcomes:
Locations:
city: Muscle Shoals
country: United States
facility: Northwest Alabama Cancer Center
state: Alabama
city: Casa Grande
country: United States
facility: Donald W. Hill, MD
state: Arizona
city: Corona
country: United States
facility: Compassionate Cancer Care Medical Group, Inc
state: California
city: Fountain Valley
country: United States
facility: Compassionate Cancer Care Medical Group Inc
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Palm Springs
country: United States
facility: Desert Hospital Comprehensive Cancer Center
state: California
city: Riverside
country: United States
facility: Compassionate Cancer Care Medical Group, Inc
state: California
city: Whittier
country: United States
facility: American Institute Research
state: California
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Jacksonville
country: United States
facility: Baptist Cancer Institute
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Metairie
country: United States
facility: Brinz, Burroff, Gurtler, & Russo
state: Louisiana
city: Oklahoma City
country: United States
facility: Cancer Specialists Of Oklahoma
state: Oklahoma
city: East Providence
country: United States
facility: Pharma Resource
state: Rhode Island
city: Austin
country: United States
facility: Austin Cancer Centers
state: Texas
city: San Juan
country: Puerto Rico
facility: Local Institution
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: 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.