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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01930864
Other study ID # MetIri
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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