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

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.

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Key information

Conditions

Colorectal Cancer Metastatic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Charles-Le Moyne, Greenfield Park, Quebec, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

PeriPharm

Other

Collaborators

Personalized Medicine Partnership for Cancer

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2018
First posted: May 12, 2014
Registry last updated: Mar 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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