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

Colorectal Cancer Metastatic Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02135757
• Other study ID #: PMPC-02
• Status: Completed
• First received: May 8, 2014
• Last updated: March 29, 2018
• Start date: August 2014
• Est. completion date: March 2018

Study information

• Verified date: March 2018
• Source: PeriPharm
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Locations

Country	Name	City	State
Canada	Hôpital Charles-Le Moyne	Greenfield Park	Quebec
Canada	Jewish General Hospital	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
PeriPharm	Personalized Medicine Partnership for Cancer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pharmacoeconomic impact of panitumumab for the treatment of metastatic colorectal cancer in a real-life setting	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	Identification of blood biomarkers that confer significant improvement in progression-free survival in patients treated with panitumumab.	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).