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

NCT02139215 | Completed

• 1 other identifier: PMPC-01
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 5

Brief Summary

This is a phase IV multicenter trial to evaluate real-world health outcomes and economic impact of panitumumab versus standard-of-care (SOC) in the treatment of patients with chemotherapy-refractory metastatic colorectal cancer (mCRC). The study will enable real-life health economics and outcome research (HEOR) to assess the impact of panitumumab in the Quebec population. The primary objective is to evaluate real-world health outcomes and economic impact of panitumumab in the treatment of patients with chemotherapy-refractory mCRC in comparison with SOC. 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. Patients with a mutated KRAS gene will be treated with standard-of-care (SOC) and patients with a non-mutated (wild type) KRAS gene will be treated with panitumumab. 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.

Conditions

Colorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• years of age or older.

Sponsors & Collaborators

• PeriPharm: lead
• Personalized Medicine Partnership for Cancer: collaborator

Study Sites (5)

CSSS Alphonse-Desjardins (CHAU, Hôtel-Dieu de Lévis)

Lévis, Quebec, G6V 3Z1, Canada

Location

CIUSSS de l'Est-de-l'Île-de-Montréal (Hôpital Maisonneuve-Rosemont)

Montreal, Quebec, H1T 2M4, Canada

Location

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3J4, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke (CHUS)

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Centre Hospitalier Universitaire de Québec (CHU, Hôtel-Dieu de Québec)

Québec, G1R 2J6, Canada

Location

Study Officials

• Jean Lachaine, PhD

  PeriPharm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 15, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 30, 2018

Record last verified: 2018-03

Locations

CA (5)