Observational Study of Vectibix With Chemotherapy for Metastatic Colorectal Cancer Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

213 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-10

Study Completion Date

2016-11-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Wild-type RAS Metastatic Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Metastatic Colorectal Cancer

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

Panitumumab + Chemotherapy

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Vectibix®

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No