Observational Study of Vectibix With Chemotherapy for Metastatic Colorectal Cancer Patients

Completed

• Conditions: Wild-type RAS Metastatic Colorectal Cancer
• Interventions: Other: Panitumumab + Chemotherapy

• Registration Number: NCT01732783
• Lead Sponsor: Amgen

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-20
• Study First Submitted QC: 2012-11-20
• Study First Posted: 2012-11-26
• Study Start: 2012-12-10
• Primary Completion: 2016-11-30
• Study Completion: 2016-11-30
• Results First Submitted: 2017-11-22
• Results First Submitted QC: 2017-11-22
• Results First Posted: 2018-08-20
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Metastatic Colorectal Cancer	Panitumumab + Chemotherapy	Participants with wild-type RAS metastatic colorectal cancer who were receiving panitumumab in combination with chemotherapy.

Primary Outcome Measures

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

Secondary Outcome Measures

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