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

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ClinicalTrials.gov Identifier: NCT02135757
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : March 30, 2018
Sponsor:
Collaborator:
Personalized Medicine Partnership for Cancer
Information provided by (Responsible Party):
PeriPharm

Brief 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.


Condition or disease
Colorectal Cancer Metastatic

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Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : August 2014
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Panitumumab




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chemotherapy-refractory metastatic colorectal cancer from participating hospitals in Quebec.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135757


Locations
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Canada, Quebec
Hôpital Charles-Le Moyne
Greenfield Park, Quebec, Canada, J4V 2H1
Jewish General Hospital
Montréal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
PeriPharm
Personalized Medicine Partnership for Cancer
Investigators
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Principal Investigator: Jean Lachaine, PhD PeriPharm

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Responsible Party: PeriPharm
ClinicalTrials.gov Identifier: NCT02135757     History of Changes
Other Study ID Numbers: PMPC-02
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Panitumumab
Antineoplastic Agents, Immunological
Antineoplastic Agents