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Metformin Plus Irinotecan for Refractory Colorectal Cancer

Primary Purpose

Colorectal Neoplasms, Adenocarcinoma

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
metformin
irinotecan
Sponsored by
Barretos Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring metformin, colorectal cancer, chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or older
  • Biopsy-proven colorectal adenocarcinoma
  • Ineligibility for curative intent therapy, e.g., surgery or radiation
  • Disease progression after oxaliplatin (either adjuvant or palliative), fluoropyrimidine (either adjuvant or palliative), irinotecan, and if Kras wild type a anti-EGFR therapy
  • Assessable disease according to RECIST v1.1

Exclusion Criteria:

  • known hypersensitivity to metformin or irinotecan
  • Uncontrolled Central nervous system metastasis
  • Acute or chronic severe infection

Sites / Locations

  • Barretos Cancer HospitalRecruiting
  • State University of Campinas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

metfomin + irinotecan

Arm Description

Irinotecan 350mg/m² q21d + metformin up to 2500mg/d until disease progression, prohibitive toxicity or consent withdrawal

Outcomes

Primary Outcome Measures

Non-Progression at week 12th of treatment
Non-Progression at week 12th of treatment

Secondary Outcome Measures

Progression-free survival
Progression-free survival
Overall Survival
Overall Survival
Quality of life
Measured by EORTC QLQ C30
Safety
Assessment of toxicity according to CTC 4.0

Full Information

First Posted
August 26, 2013
Last Updated
June 21, 2017
Sponsor
Barretos Cancer Hospital
Collaborators
University of Campinas, Brazil, AC Camargo Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01930864
Brief Title
Metformin Plus Irinotecan for Refractory Colorectal Cancer
Official Title
Phase II Trial of Metformin Combined to Irinotecan for Refractory Metastatic or Recurrent Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barretos Cancer Hospital
Collaborators
University of Campinas, Brazil, AC Camargo Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
MetIri seeks to identify if metformin combined to irinotecan can improve tumor control.
Detailed Description
MetIri is a two-stage single arm Phase II assessing the role of combination of metformin to irinotecan for colorectal cancer patients already treat with oxaliplatin, fluoropyrimidine, irinotecan and an anti-EGFr antibody if KRAS wild-type.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Adenocarcinoma
Keywords
metformin, colorectal cancer, chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
metfomin + irinotecan
Arm Type
Experimental
Arm Description
Irinotecan 350mg/m² q21d + metformin up to 2500mg/d until disease progression, prohibitive toxicity or consent withdrawal
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
metformin up to 2500mg/d
Intervention Type
Drug
Intervention Name(s)
irinotecan
Intervention Description
Irinotecan 350 mg/m² IV q21d
Primary Outcome Measure Information:
Title
Non-Progression at week 12th of treatment
Description
Non-Progression at week 12th of treatment
Time Frame
12th week
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
Progression-free survival
Time Frame
12th week
Title
Overall Survival
Description
Overall Survival
Time Frame
12th week
Title
Quality of life
Description
Measured by EORTC QLQ C30
Time Frame
12th week
Title
Safety
Description
Assessment of toxicity according to CTC 4.0
Time Frame
12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older Biopsy-proven colorectal adenocarcinoma Ineligibility for curative intent therapy, e.g., surgery or radiation Disease progression after oxaliplatin (either adjuvant or palliative), fluoropyrimidine (either adjuvant or palliative), irinotecan, and if Kras wild type a anti-EGFR therapy Assessable disease according to RECIST v1.1 Exclusion Criteria: known hypersensitivity to metformin or irinotecan Uncontrolled Central nervous system metastasis Acute or chronic severe infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joao Paulo SN Lima, MD
Phone
551733216600
Ext
7128
Email
joao.lima@accamargo.org.br
First Name & Middle Initial & Last Name or Official Title & Degree
Arinilda C Bragagnoli, MD
Phone
551733216600
Ext
6829
Email
aryscampos@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joao Paulo SN Lima, MD, PhD
Organizational Affiliation
AC Camargo Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barretos Cancer Hospital
City
Barretos
State/Province
SP
ZIP/Postal Code
14784-400
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joao Paulo SN Lima, MD
Phone
551733216600
Ext
6829
Email
joao.lima@accamargo.org.br
First Name & Middle Initial & Last Name & Degree
Arinilda C Bragagnoli, MD
Phone
551733216600
Ext
6829
Email
aryscampos@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Arinilda C Bragagnoli, MD
Facility Name
State University of Campinas
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
1300000
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lígia T Macedo, MD
Email
ligaimed@gmail.com
First Name & Middle Initial & Last Name & Degree
Ligia T Macedo, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Upon data collection, the info will be put on a online database
Citations:
PubMed Identifier
21543517
Citation
Rocha GZ, Dias MM, Ropelle ER, Osorio-Costa F, Rossato FA, Vercesi AE, Saad MJ, Carvalheira JB. Metformin amplifies chemotherapy-induced AMPK activation and antitumoral growth. Clin Cancer Res. 2011 Jun 15;17(12):3993-4005. doi: 10.1158/1078-0432.CCR-10-2243. Epub 2011 May 4.
Results Reference
background

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Metformin Plus Irinotecan for Refractory Colorectal Cancer

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