Study to Evaluate Real-world Pharmacoeconomics and Resistance Mechanisms of Panitumumab in Metastatic Colorectal Cancer Patients

March 29, 2018 updated by: PeriPharm

A Phase IV Multicenter Trial to Evaluate Real-world Health Outcomes, Economic Impact and Resistance Mechanisms of Panitumumab in the Treatment of Patients With Chemotherapy-refractory Metastatic Colorectal Cancer

This is a phase IV multicenter trial to evaluate real-world health outcomes, economic impact and resistance mechanisms of panitumumab in the treatment of patients with chemotherapy-refractory metastatic colorectal cancer (mCRC).

This study will address two anticipated issues surrounding personalized medicine and treatment with panitumumab. First, it will enable to assess the economic impact of panitumumab in a real-life setting (HEOR study). Second, it will identify new blood-based mechanisms of resistance, which may lead to new avenues for combination therapy in metastatic colorectal cancer (Blood study).

The primary objective is to collect information on quality of life and health care resource utilization by patients diagnosed with metastatic colorectal cancer. The secondary objectives are to confirm survival data, to assess the quality of life of patients and to assess the health care resource utilization of patients. The blood biomarker study objective is to determine blood-based biomarkers of response or resistance to panitumumab.

Patients with a mutated KRAS gene will be treated with standard-of-care (SOC) and will participate to the HEOR study only. Patients with a non-mutated (wild type) KRAS gene will be treated with panitumumab and will participate to the HEOR study and to the blood biomarker study.

During the course of the study, data will be collected on quality of life and work productivity. Patients will be asked to fill a set of questionnaires at their recruitment in the study and at every 3 months after treatment initiation. For patients participating to the blood study (patients with a wild type KRAS), blood samples will be collected before patients start their treatment, at every treatment and when they discontinue their treatment.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Hôpital Charles-Le Moyne
      • Montréal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chemotherapy-refractory metastatic colorectal cancer from participating hospitals in Quebec.

Description

Inclusion Criteria:

  • Patients with a histologically confirmed diagnosis of mCRC.
  • Immunohistochemical evidence of EGFR expression.
  • ECOG performance status of 0, 1 or 2.
  • Patients refractory to fluoropyrimidine, oxaliplatin, and irinotecan chemotherapy regimens
  • Patients with a wt KRAS scheduled to receive panitumumab as a single agent for the third-line treatment of mCRC or patients with a mt KRAS scheduled to receive SOC for third-line treatment of mCRC.
  • Signed and dated IRB-approved informed consent document.
  • Ability to read and understand English or French.
  • 18 years of age or older.

Exclusion Criteria:

  • Acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The pharmacoeconomic impact of panitumumab for the treatment of metastatic colorectal cancer in a real-life setting
Time Frame: From the date of registration until date of death from any cause, assessed up to 38 months.
Pharmacoeconomic impact (cost-effectiveness and cost-utility) will be evaluated by questionnaires completed by the patient and caregiver. These include quality of life, health resource utilization, work productivity and activity impairment, and health questionnaires.
From the date of registration until date of death from any cause, assessed up to 38 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of blood biomarkers that confer significant improvement in progression-free survival in patients treated with panitumumab.
Time Frame: From the date of registration until the date of disease progression, assessed up to 24 months (estimation).
Plasma will be isolated from patients pre-treatment, at every disease assessment and at progression of disease.
From the date of registration until the date of disease progression, assessed up to 24 months (estimation).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PeriPharm

Collaborators

Personalized Medicine Partnership for Cancer

Investigators

  • Principal Investigator: Jean Lachaine, PhD, PeriPharm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

May 8, 2014

First Submitted That Met QC Criteria

May 8, 2014

First Posted (Estimate)

May 12, 2014

Study Record Updates

Last Update Posted (Actual)

March 30, 2018

Last Update Submitted That Met QC Criteria

March 29, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMPC-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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