Metformin Plus Irinotecan for Refractory Colorectal Cancer | NCT01930864

Studies
Metformin Plus Irinotecan for Refractory Colorectal Cancer

NCT01930864

Sponsor

Barretos Cancer Hospital

Status

Unknown status

Last Update Posted

Jun 22, 2017Actual

Enrollment

41Estimated

Phase

Phase 2

Conditions

Colorectal Neoplasms
Adenocarcinoma

Interventions

metformin
irinotecan

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2015Actual

Primary Completion Date

Dec 1, 2020Estimated

Completion Date

Dec 1, 2020Estimated

First Submitted Date

Aug 26, 2013

First Submission Date that Met QC Criteria

Aug 26, 2013

First Posted Date

Aug 29, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2017

Last Update Posted Date

Jun 22, 2017Actual

Name	Class
University of Campinas, Brazil	OTHER
AC Camargo Cancer Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Estimated

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
metformin	Drug	metformin up to 2500mg/d	metfomin + irinotecan
irinotecan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Non-Progression at week 12th of treatment	Non-Progression at week 12th of treatment	12th week

Secondary Outcomes

Measure	Description	Time Frame
Progression-free survival	Progression-free survival	12th week
Overall Survival	Overall Survival	12th week

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Joao Paulo SN Lima, MD	Contact	551733216600	7128	joao.lima@accamargo.org.br
Arinilda C Bragagnoli, MD	Contact	551733216600	6829	aryscampos@yahoo.com.br

Overall Officials

Name	Affiliation	Role
Joao Paulo SN Lima, MD, PhD	AC Camargo Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Barretos Cancer Hospital	Recruiting	Barretos	São Paulo	14784-400	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21543517	Background	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.

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals
D002166

ID	Term
D015179	Colorectal Neoplasms
D000230	Adenocarcinoma