Observational Study of Vectibix With Chemotherapy for Metastatic Colorectal Cancer Patients

Overview

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).

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 30, 2016

Interventions

  • 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.

Arms, Groups and Cohorts

  • Metastatic Colorectal Cancer
    • Participants with wild-type RAS metastatic colorectal cancer who were receiving panitumumab in combination with chemotherapy.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Number of Participants With at Least One Hospitalization
    • Time Frame: 12 months
  • Types of Hospital Visit
    • Time Frame: 12 months
    • Participants may have had more than one type of hospital visit.
  • Duration of Hospital Stay
    • Time Frame: 12 months
  • Reasons for Hospitalization
    • Time Frame: 12 months
    • Participants may have had more than one hospital visit and/or reason for a hospital visit.
  • Percentage of Participants With an Overall Response
    • Time Frame: 12 months
    • 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).
  • Number of Participants With Resectability
    • Time Frame: 12 months
    • Resectability denotes whether a participant became resectable during the study.
  • Number of Participants With Anti-cancer Treatment After Panitumumab Discontinuation
    • Time Frame: 12 months
  • Type of Post-Panitumumab Anti-cancer Treatment
    • Time Frame: 12 months
    • Participants may have received more than one type of anti-cancer treatment that was initiated after panitumumab discontinuation.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Amgen
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • MD, Study Director, Amgen

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