Observational Study of Vectibix With Chemotherapy for Metastatic Colorectal Cancer Patients

Amgen

Status: Completed

Conditions: Wild-type RAS Metastatic Colorectal Cancer

Treatments: Other: Panitumumab + Chemotherapy

Study type: Observational

Funder types: Industry

Identifiers

NCT01732783

20120100

Details and patient eligibility

About

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).

Enrollment: 213 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

213 participants in 1 patient group

Metastatic Colorectal Cancer

Description:

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

Treatment:

Other: Panitumumab + Chemotherapy