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Advanced CancerPhase 2NCT00698841

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

A Phase 2 study testing Cetuximab in people with Advanced Cancer, run by Eli Lilly and Company at 16 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer
What is being tested?
Cetuximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
16 sitesin 2 countries
Study dates
Feb 2009to Feb 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

16 sites in 2 countries.

16 sites in 2 countries

United States15 sites

  • Austin Cancer Centers

    Austin, Texas, 78759

  • Donald W. Hill, MD

    Casa Grande, Arizona, 85222

  • Compassionate Cancer Care Medical Group, Inc

    Corona, California, 92879

  • Pharma Resource

    East Providence, Rhode Island, 02915

  • Compassionate Cancer Care Medical Group Inc

    Fountain Valley, California, 92708

  • Baptist Cancer Institute

    Jacksonville, Florida, 32207

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • Brinz, Burroff, Gurtler, & Russo

    Metairie, Louisiana, 70006

  • Northwest Alabama Cancer Center

    Muscle Shoals, Alabama, 35661

  • Ocala Oncology Center

    Ocala, Florida, 34471

  • Cancer Specialists Of Oklahoma

    Oklahoma City, Oklahoma, 73112

  • Desert Hospital Comprehensive Cancer Center

    Palm Springs, California, 92262

  • Compassionate Cancer Care Medical Group, Inc

    Riverside, California, 92501

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • American Institute Research

    Whittier, California, 90603

Other trials in United States

Puerto Rico1 site

  • Local Institution

    San Juan, Pr, 00910

Other trials in Puerto Rico

About this study

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

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
Being tested
Cetuximab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CetuximabDrug

    Also called Erbitux

    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.

Study groups in NCT00698841
Study groupRoleWhat they receive
CetuximabExperimentalNot described
Receives: Drug: Cetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (6)

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

    12-Lead continuous digital ECG data were collected at preselected time points at baseline visit and on Days 1, 8, 15, 22, and 29. The PR interval is the time from the onset of the P wave to the beginning of the QRS complex. The QRS interval=deflections in the ECG, comprising Q, R, and S waves, that represent depolarization of the ventricles. Clinically significant was determined at the investigator's discretion.

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

  2. 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

    AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, or is an important medical event. Treatment related=possibly, probably, or certainly related to or of unknown relationship to study treatment.

    Measured: Baseline through Cycle 1 (28 days), continuously

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

    AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with treatment. AEs of special interest have been sponsor-selected based on the known clinical effects of cetuximab. Treatment related=possibly, probably, or certainly related to or of unknown relationship to study treatment. CTC Grade 1: Mild. Grade 2: Moderate. Grade 3: Severe or medically significant but not immediately life-threatening. Grade 4: Life-threatening.

    Measured: Baseline through Cycle 1 (28 days), continuously

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

    BL=baseline; OS=on-study; ULN=upper level of normal. Albumin,low (g/dL) Grade 1:<LLN-30, Grade 2:<30-20, Grades 3\&4:<20. Aspartate aminotransferase (AST)(U/L) Grade 1:>ULN-2.5*ULN, Grade 2:>2.5-5.0*ULN, Grade 3:>5.0-20.0*ULN, Grade 4:>20.0*ULN. Total bilirubin, high Grade 1:ULN-1.5*ULN, Grade 2:>1.5-3.0*ULN, Grade 3:>3.0-10.0*ULN, Grade 4:>10.0*ULN. Alkaline phosphatase (ALP) (U/L) Grade 1:>ULN-2.5*ULN, Grade 2:>2.5-5.0*ULN, Grade 3:>5.0-20.0*ULN, Grade 4:>20.0*ULN. Creatinine (mg/dL) Grade 1:>ULN-1.5*ULN, Grade 2:>1.5-3.0*ULN, Grade 3:>3.0-6.0*ULN, Grade 4:>6.0*ULN.

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

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

    BL=baseline; OS=on-study; LLN=lower level of normal; ULN=upper level of normal. Sodium, low(mmol/L) Grades 1\&2:<LLN-130, Grade 3:<130-120, Grade 4:<120. Sodium, high (mmol/L) Grade 1:>ULN-150, Grade 2:>150-155, Grade 3:>155-160, Grade 4:>160. Potassium, high (mmol/L) Grade 1:>ULN-5.5, Grade 2:>5.5-6.0, Grade 3:>6.0-7.0, Grade 4:>7.0. Glucose, low(mg/dL) Grade 1:<LLN-55, Grade 2:<55-40, Grade 3:<40-30, Grade 4:<30. Glucose, high (mg/dL) Grade 1:>ULN-160, Grade 2:>160-250, Grade 3:>250-500, Grade 4:>500. Calcium, high(mg/dL) Grade 1:>ULN-11.5, Grade 2:>11.5-12.5, Grade 3:>12.5-13.5, Grade 4:>13.

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

  6. Number of Participants With Hematology Abnormalities by Worst CTC Grade at Baseline and On-study

    BL=baseline; OS=on-study; LLN=lower level of normal. Laboratory values assessed using CTC for AEs, Version 3.0. Hemoglobin (g/dL) Grade 1:<LLN to 10.0, Grade 2:<10.0 to 8.0, Grade 3:<8.0 to 6.5, Grade 4:<6.5. Platelets Grade 1:LLN to 75.0*10^9/L, Grade 2:<75.0 to 50.0*10^9/L, Grade 3:<50.0 to 25.0*10^9/L, Grade 4:<25.0 to 10^9/L. White blood cells Grade 1:<LLN to 3.0*10^9/L, Grade 2:<3.0 to 2.0*10^9/L, Grade 3:<2.0 to 1.0*10^9/L, Grade 4:<1.0*10^9/L. Neutrophils Grade 1:<LLN to 1.5*10^9/L, Grade 2:<1.5 to 1.0*10^9/L, Grade 3:<1.0 to 0.5*10^9/L, Grade 4:<0.5*10^9/L.

    Measured: At screening, weekly prior to start of cetuximab infusion, at end of Cycle 1 (28 days), and at 30-day follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2008 (estimated)
  2. Study startFeb 2009
  3. Primary completionFeb 2010
  4. Study completionFeb 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00698841
Sponsor's protocol ID
CA225-315
Status last verified
Nov 2015
First submitted
16 Jun 2008
Last updated
24 Dec 2015
Data monitoring committee
No

Publications

  • 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.

    PubMed 23589315

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cetuximab in people with Advanced Cancer, run by Eli Lilly and Company at 16 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Clinically Meaningful Prolongation of the QT Interval Corrected for Heart Rate (QTc) From Time-matched Baseline (time frame: Baseline, Day 1, and then weekly to end of Cycle 1 (28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00698841, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2015.

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