Metformin Plus Irinotecan for Refractory Colorectal Cancer

Colorectal Neoplasms Clinical Trial

Official title:

Phase II Trial of Metformin Combined to Irinotecan for Refractory Metastatic or Recurrent Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01930864
• Other study ID #: MetIri
• Status: Recruiting
• Phase: Phase 2
• First received: August 26, 2013
• Last updated: June 21, 2017
• Start date: September 1, 2015
• Est. completion date: December 1, 2020

Study information

• Verified date: June 2017
• Source: Barretos Cancer Hospital
• Contact: Joao Paulo SN Lima, MD
• Phone: 551733216600
• Email: joao.lima[@]accamargo.org.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 41
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Colorectal Neoplasms

Intervention

Drug:
• metformin
metformin up to 2500mg/d
• irinotecan
Irinotecan 350 mg/m² IV q21d

Locations

Country	Name	City	State
Brazil	Barretos Cancer Hospital	Barretos	SP
Brazil	State University of Campinas	Campinas	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
Barretos Cancer Hospital	AC Camargo Cancer Center, University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Rocha GZ, Dias MM, Ropelle ER, Osório-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-Progression at week 12th of treatment	Non-Progression at week 12th of treatment	12th week
Secondary	Progression-free survival	Progression-free survival	12th week
Secondary	Overall Survival	Overall Survival	12th week
Secondary	Quality of life	Measured by EORTC QLQ C30	12th week
Secondary	Safety	Assessment of toxicity according to CTC 4.0	12th week