Metformin Plus Irinotecan for Refractory Colorectal Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2015 by Barretos Cancer Hospital
Sponsor:
Information provided by (Responsible Party):
Barretos Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01930864
First received: August 26, 2013
Last updated: July 30, 2015
Last verified: July 2015
  Purpose

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


Condition Intervention Phase
Colorectal Neoplasms
Adenocarcinoma
Drug: Metformin
Drug: Irinotecan
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Metformin Combined to Irinotecan for Refractory Metastatic or Recurrent Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Barretos Cancer Hospital:

Primary Outcome Measures:
  • Non-Progression at week 12th of treatment [ Time Frame: 12th week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 12th week ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 12th week ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12th week ] [ Designated as safety issue: No ]
    Measured by EORTC QLQ C30

  • Safety [ Time Frame: 12th week ] [ Designated as safety issue: Yes ]
    Assessment of toxicity according to CTC 4.0


Estimated Enrollment: 41
Study Start Date: September 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 anti-EGFr antibody if Kras wild type.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • CNS metastasis
  • Acute or chronic severe infection
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01930864

Contacts
Contact: Joao Paulo SN Lima, MD 551733216600 ext 7128 jpsnlima@yahoo.com.br
Contact: Arinilda C Bragagnoli, MD 551733216600 ext 6829 aryscampos@yahoo.com.br

Locations
Brazil
Barretos Cancer Hospital Not yet recruiting
Barretos, SP, Brazil, 14784-400
Contact: Joao Paulo SN Lima, MD    551733216600 ext 7128    joaopaulo.oncologia@hcancerbarretos.com.br   
Contact: Arinilda C Bragagnoli, MD    551733216600 ext 6829    aryscampos@yahoo.com.br   
Principal Investigator: Joao Paulo SN Lima, MD, PhD         
State University of Campinas Not yet recruiting
Campinas, São Paulo, Brazil, 1300000
Contact: Lígia T Macedo, MD       ligaimed@gmail.com   
Principal Investigator: Ligia T Macedo, MD         
Sponsors and Collaborators
Barretos Cancer Hospital
Investigators
Principal Investigator: Joao Paulo SN Lima, MD, PhD Barretos Cancer Hospital
  More Information

No publications provided

Responsible Party: Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT01930864     History of Changes
Other Study ID Numbers: MetIri
Study First Received: August 26, 2013
Last Updated: July 30, 2015
Health Authority: Brazil: Ethics Committee

Keywords provided by Barretos Cancer Hospital:
metformin
colorectal cancer
chemotherapy

Additional relevant MeSH terms:
Colorectal Neoplasms
Adenocarcinoma
Carcinoma
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Rectal Diseases
Irinotecan
Metformin
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on July 30, 2015