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Metformin Plus Irinotecan for Refractory Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01930864
Recruitment Status : Recruiting
First Posted : August 29, 2013
Last Update Posted : June 22, 2017
University of Campinas, Brazil
AC Camargo Cancer Center
Information provided by (Responsible Party):
Barretos Cancer Hospital

Brief Summary:
MetIri seeks to identify if metformin combined to irinotecan can improve tumor control.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Adenocarcinoma Drug: metformin Drug: irinotecan Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Metformin Combined to Irinotecan for Refractory Metastatic or Recurrent Colorectal Cancer
Actual Study Start Date : September 1, 2015
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: metfomin + irinotecan
Irinotecan 350mg/m² q21d + metformin up to 2500mg/d until disease progression, prohibitive toxicity or consent withdrawal
Drug: metformin
metformin up to 2500mg/d

Drug: irinotecan
Irinotecan 350 mg/m² IV q21d

Primary Outcome Measures :
  1. Non-Progression at week 12th of treatment [ Time Frame: 12th week ]
    Non-Progression at week 12th of treatment

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 12th week ]
    Progression-free survival

  2. Overall Survival [ Time Frame: 12th week ]
    Overall Survival

  3. Quality of life [ Time Frame: 12th week ]
    Measured by EORTC QLQ C30

  4. Safety [ Time Frame: 12th week ]
    Assessment of toxicity according to CTC 4.0

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01930864

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Contact: Joao Paulo SN Lima, MD 551733216600 ext 7128
Contact: Arinilda C Bragagnoli, MD 551733216600 ext 6829

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Barretos Cancer Hospital Recruiting
Barretos, SP, Brazil, 14784-400
Contact: Joao Paulo SN Lima, MD    551733216600 ext 6829   
Contact: Arinilda C Bragagnoli, MD    551733216600 ext 6829   
Principal Investigator: Arinilda C Bragagnoli, MD         
State University of Campinas Not yet recruiting
Campinas, São Paulo, Brazil, 1300000
Contact: Lígia T Macedo, MD   
Principal Investigator: Ligia T Macedo, MD         
Sponsors and Collaborators
Barretos Cancer Hospital
University of Campinas, Brazil
AC Camargo Cancer Center
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Principal Investigator: Joao Paulo SN Lima, MD, PhD AC Camargo Cancer Center

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Responsible Party: Barretos Cancer Hospital Identifier: NCT01930864     History of Changes
Other Study ID Numbers: MetIri
First Posted: August 29, 2013    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon data collection, the info will be put on a online database

Keywords provided by Barretos Cancer Hospital:
colorectal cancer

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents