Observational Study of Vectibix With Chemotherapy for Metastatic Colorectal Cancer Patients

Prospective Observational Cohort Study to Describe the Use of Vectibix® in Combination With Chemotherapy in Routine Clinical Practice for Patients With Wild-type RAS Metastatic Colorectal Cancer

The primary objective was to describe the pattern of use of panitumumab (Vectibix®) in combination with chemotherapy in patients with wild-type rat sarcoma viral oncogene homolog (RAS) metastatic colorectal cancer (mCRC): as first-line treatment in combination with FOLFOX or FOLFIRI or second-line treatment in combination with FOLFIRI in patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).

Study Overview

• Status: Completed
• Conditions: Wild-type RAS Metastatic Colorectal Cancer
• Intervention / Treatment: Other: Panitumumab + Chemotherapy

• Study Type: Observational
• Enrollment (Actual): 213

Participation Criteria

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

All treatment centres (inpatient and outpatient) with a focus on treating patients with mCRC. Centres will be selected to represent academic, oncology and specialist settings and to provide geographical diversity in France and Germany.

Description

Inclusion Criteria

• Subject is ≥ 18 years of age at date of enrolment
• Histologically or cytologically confirmed carcinoma of colon or rectum
• Subject with metastatic carcinoma of colon or rectum
• Confirmed wild-type RAS status of tumour
• Subjects whose care will be managed primarily by the enrolling physician and/ or all records will be available
• Tumour assessment (ie, computed tomography [CT]/magnetic resonance imaging [MRI]) within 12 weeks (84 days) prior to first Vectibix® infusion.
• Subjects treated with at least one infusion of Vectibix® in combination with chemotherapy a maximum of 84 days before entering study: first-line in combination with FOLFOX (folinic acid, leucovorin, fluorouracil [5FU], oxaliplatin) or second-line in combination with FOLFIRI (folinic acid, leucovorin, 5FU, irinotecan) in subjects who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) for treatment of wild-type RAS mCRC per approved prescribing information
• Subject or subject's legally acceptable representative has provided informed consent (for countries where required per local regulations)
• Subjects treated with Vectibix® in accordance with the current version of the Summary of Product Characteristics (SmPC)

Exclusion Criteria

• Ongoing or planned concurrent participation in any clinical study involving Investigational Product that has not been approved by the European Medicines Agency for any indication
• Ongoing or planned concurrent participation in any clinical study where the dosing of Vectibix® is determined by the protocol (participation in clinical trials on an approved drug and observational trials are permitted but these cannot mandate how mCRC should be treated)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Metastatic Colorectal Cancer; Participants with wild-type RAS metastatic colorectal cancer who were receiving panitumumab in combination with chemotherapy.	Other: Panitumumab + Chemotherapy; Participants receiving panitumumab in combination with chemotherapy as prescribed by the treating physician prior to enrollment in this study and according to routine clinical practice for patients with wild-type RAS metastatic colorectal cancer.; Other Names: Vectibix®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Panitumumab Infusions		12 months
Cumulative Dose of Panitumumab		12 months
Maximum Dose of Panitumumab		12 months
Duration of Panitumumab Exposure	Duration of exposure is the time from the first to the last panitumumab infusion	12 months
Mean Interval Between Panitumumab Infusions		12 months
Percentage of Participants With at Least One Panitumumab Dose Reduction		12 months
Percentage of Participants With at Least One Panitumumab Dose Delay		12 months
Reasons for Discontinuation of Panitumumab		12 months
Duration of Exposure of All Concomitant Chemotherapy	Duration of exposure is the time from the first date to the last date of chemotherapy administration.	12 months
Percentage of Participants With at Least One Concomitant Chemotherapy Dose Reduction		12 months
Percentage of Participants With at Least One Concomitant Chemotherapy Dose Delay		12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With at Least One Hospitalization		12 months
Types of Hospital Visit	Participants may have had more than one type of hospital visit.	12 months
Duration of Hospital Stay		12 months
Reasons for Hospitalization	Participants may have had more than one hospital visit and/or reason for a hospital visit.	12 months
Percentage of Participants With an Overall Response	Tumor response was assessed by the investigator using standard radiological imaging. Overall response is defined as a best tumor response of complete response or partial response according to Response Evaluation Criteria In Solid Tumours (RECIST).	12 months
Number of Participants With Resectability	Resectability denotes whether a participant became resectable during the study.	12 months
Number of Participants With Anti-cancer Treatment After Panitumumab Discontinuation		12 months
Type of Post-Panitumumab Anti-cancer Treatment	Participants may have received more than one type of anti-cancer treatment that was initiated after panitumumab discontinuation.	12 months

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2012
• Primary Completion (Actual): November 30, 2016
• Study Completion (Actual): November 30, 2016

Study Registration Dates

• First Submitted: November 20, 2012
• First Submitted That Met QC Criteria: November 20, 2012
• First Posted (Estimate): November 26, 2012

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Vectibix; Metastatic Colorectal Cancer; Wild-type RAS
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Panitumumab
• Other Study ID Numbers: 20120100