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Metastatic Colorectal Cancer Treated With Regorafenib and FOLFIRI

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Regorafenib
UGT1A1 genotyping (TA6/TA6)
UGT1A1 genotyping (TA6/TA7)
UGT1A1 genotyping (TA7/TA7)
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring EGFR, KRAS, tumor sideness, FOLFIRI, regorafenib, metastatic colorectal cancer

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chung-Ho Memorial Hospital, Kaohsiung Medical University:

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Regorafenib plus FOLFIRI

Arm Description

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.

Outcomes

Primary Outcome Measures

Progression-free survival
Time from treatment to disease progresses

Secondary Outcome Measures

Overall survival
Time from treatment to death of subjectives
Best objective response
best response recorded during treatment
Disease control rate
Rate of best objective response, including complete response, partial response and stabel disease
Rate of treatment-associated adverse events.
Common Terminology Criteria for Adverse Events version 3.0 was used for evaluating treatment-associated adverse events.

Full Information

First Posted
October 1, 2018
Last Updated
October 4, 2018
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03698253
Brief Title
Metastatic Colorectal Cancer Treated With Regorafenib and FOLFIRI
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2013 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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: This is a retrospective study. 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. Duration of Treatment: Treatment was administered until disease progressed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
EGFR, KRAS, tumor sideness, FOLFIRI, regorafenib, metastatic colorectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regorafenib plus FOLFIRI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Regorafenib
Other Intervention Name(s)
stivarga
Intervention Description
Regorafenib is administered at dose of 120 mg daily for 3 weeks in a 4-week cycle
Intervention Type
Genetic
Intervention Name(s)
UGT1A1 genotyping (TA6/TA6)
Intervention Description
The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 260 mg/m2
Intervention Type
Genetic
Intervention Name(s)
UGT1A1 genotyping (TA6/TA7)
Intervention Description
The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 240 mg/m2
Intervention Type
Genetic
Intervention Name(s)
UGT1A1 genotyping (TA7/TA7)
Intervention Description
The dosage of irinotecan in FOLFIRI is escalated from 120mg/m2 to180 mg/m2
Primary Outcome Measure Information:
Title
Progression-free survival
Description
Time from treatment to disease progresses
Time Frame
From date of initiaton of treatment until the date of first documented progression, assessed up to 23 months
Secondary Outcome Measure Information:
Title
Overall survival
Description
Time from treatment to death of subjectives
Time Frame
From date of initiation of treatment until the date of death from any cause, assessed up to 23 months
Title
Best objective response
Description
best response recorded during treatment
Time Frame
From date of initiation of treatment until the date of disease progression, assessed up to 23 months
Title
Disease control rate
Description
Rate of best objective response, including complete response, partial response and stabel disease
Time Frame
From date of initiation of treatment until the date of disease progression, assessed up to 23 months
Title
Rate of treatment-associated adverse events.
Description
Common Terminology Criteria for Adverse Events version 3.0 was used for evaluating treatment-associated adverse events.
Time Frame
Adverse events is evaluated and recorded during every cycle of treatment. Up to 23 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaw-Yuan Wang, PhD
Organizational Affiliation
Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Chung-Ho Memorial Hospital, Kaohsiung Medical University:
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Metastatic Colorectal Cancer Treated With Regorafenib and FOLFIRI

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