Clinical trial NCT01732783: Observational Study of Vectibix With Chemotherapy for Metastatic Colorectal Cancer Patients
Official title: 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: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wild-type RAS Metastatic Colorectal Cancer
Keywords: Wild-type RAS
Metastatic Colorectal Cancer
Vectibix
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2012-11-26
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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).


Eligibility 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)

Primary outcomes:
measure: Total Number of Panitumumab Infusions
timeFrame: 12 months
measure: Cumulative Dose of Panitumumab
timeFrame: 12 months
measure: Maximum Dose of Panitumumab
timeFrame: 12 months
measure: Duration of Panitumumab Exposure
timeFrame: 12 months
measure: Mean Interval Between Panitumumab Infusions
timeFrame: 12 months
measure: Percentage of Participants With at Least One Panitumumab Dose Reduction
timeFrame: 12 months
measure: Percentage of Participants With at Least One Panitumumab Dose Delay
timeFrame: 12 months
measure: Reasons for Discontinuation of Panitumumab
timeFrame: 12 months
measure: Duration of Exposure of All Concomitant Chemotherapy
timeFrame: 12 months
measure: Percentage of Participants With at Least One Concomitant Chemotherapy Dose Reduction
timeFrame: 12 months
measure: Percentage of Participants With at Least One Concomitant Chemotherapy Dose Delay
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants With at Least One Hospitalization
timeFrame: 12 months
measure: Types of Hospital Visit
timeFrame: 12 months
measure: Duration of Hospital Stay
timeFrame: 12 months
measure: Reasons for Hospitalization
timeFrame: 12 months
measure: Percentage of Participants With an Overall Response
timeFrame: 12 months
measure: Number of Participants With Resectability
timeFrame: 12 months
measure: Number of Participants With Anti-cancer Treatment After Panitumumab Discontinuation
timeFrame: 12 months
measure: Type of Post-Panitumumab Anti-cancer Treatment
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: