Metastatic Colorectal Cancer Treated With Regorafenib and FOLFIRI

Prognostic Value of EGFR Expression, KRAS Mutation and Tumor Sideness in Patients With Metastatic Colorectal Cancer Treated With Regorafenib and FOLFIRI as a Third- or Fourth-line Setting

The survey is a retrospective study to evaluate the prognotic value of EGFR expression, KRAS mutations and tumor sideness in patients with metastatic colorectal cancer treated with regorafenib and FOLFIRI as a third- or fourth-line setting.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Regorafenib; Genetic: UGT1A1 genotyping (TA6/TA6); Genetic: UGT1A1 genotyping (TA6/TA7); Genetic: UGT1A1 genotyping (TA7/TA7)

Detailed Description

Primary objective:

Progression-free survival

Secondary objecive:

Overall survival, best objective response, disease control rate and adverse events

Number of Subjects: 41 patients with metastatic colorectal cancer treated with regorafenib and FOLFIRI as a third- or fourth-line setting.

Plan of the Study:

1. This is a retrospective study.
2. Study Schedule Study date: the time getting approval letter issued by both regulatory authority and institutional review board (IRB). Duration of the study: 5 years.
3. Duration of Treatment: Treatment was administered until disease progressed.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 807
    • Chung-Ho Memorial Hospital, Kaohsiung Medical University:

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 20-85 years old
• Histologically proven metastatic colorectal cancer (mCRC).
• Patients with progressing mCRC who were previously treated with FOLFOX, FOLFIRI, anti-VGFR monoclonal antibody (MoAb), and anti-EGFR MoAb if KRAS-wild-type tumors were identified.
• Patient was able to understand the requirements of the study and written informed consent was obtained from each subject.

Exclusion Criteria:

• Patients who do not meet the including criteria or unwilling to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Regorafenib plus FOLFIRI; Regimen for treatment consists of irinotecan (180 mg/m2 as a 120-min IV infusion for UGT1A1 genotyping (TA6/TA6) and UGT1A1 genotyping (TA6/TA7); 120 mg/m2 as a 120-min IV infusion for UGT1A1 genotyping (TA7/TA7)), followedby Leucovorin (400 mg/m2 IV infusion over 2 hours), and 5-FU (2800 mg/m2 IV infusion over a 46-hour period), repeated every 2 weeks. After every 2 cycles of each different dose of irinotecan, if adverse events (AEs) are under the grade 2, we will escalate the dose of 30 mg/m2. The estimated maximal dose of irinotecan is 260 mg/m2 for UGT1A1 genotyping (TA6/TA6); 240 mg/m2 for UGT1A1 genotyping (TA6/TA7); 180 mg/m2 for UGT1A1 genotyping (TA7/TA7). Regorafenib is administered at adjusted doseage of 120 mg daily for 3 weeks in a 4-week cycle.

Drug: Regorafenib; Regorafenib is administered at dose of 120 mg daily for 3 weeks in a 4-week cycle; Other Names: stivarga; Genetic: UGT1A1 genotyping (TA6/TA6); The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 260 mg/m2; Genetic: UGT1A1 genotyping (TA6/TA7); The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 240 mg/m2; Genetic: UGT1A1 genotyping (TA7/TA7); The dosage of irinotecan in FOLFIRI is escalated from 120mg/m2 to180 mg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Time from treatment to disease progresses	From date of initiaton of treatment until the date of first documented progression, assessed up to 23 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Time from treatment to death of subjectives	From date of initiation of treatment until the date of death from any cause, assessed up to 23 months
Best objective response	best response recorded during treatment	From date of initiation of treatment until the date of disease progression, assessed up to 23 months
Disease control rate	Rate of best objective response, including complete response, partial response and stabel disease	From date of initiation of treatment until the date of disease progression, assessed up to 23 months
Rate of treatment-associated adverse events.	Common Terminology Criteria for Adverse Events version 3.0 was used for evaluating treatment-associated adverse events.	Adverse events is evaluated and recorded during every cycle of treatment. Up to 23 months.

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Study Chair: Jaw-Yuan Wang, PhD, Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: October 1, 2018
• First Submitted That Met QC Criteria: October 4, 2018
• First Posted (Actual): October 5, 2018

Study Record Updates

• Last Update Posted (Actual): October 5, 2018
• Last Update Submitted That Met QC Criteria: October 4, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: EGFR; metastatic colorectal cancer; KRAS; regorafenib; FOLFIRI; tumor sideness
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: KMUHIRB-E(I)-20180270

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No