Colorectal NeoplasmsPhase 2NCT01930864
Metformin Plus Irinotecan for Refractory Colorectal Cancer
A Phase 2 study testing metformin and irinotecan in people with Colorectal Neoplasms and Adenocarcinoma, run by Barretos Cancer Hospital at 2 sites in Brazil.
Trial summary
MetIri seeks to identify if metformin combined to irinotecan can improve tumor control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Adenocarcinoma
- What is being tested?
- metformin and irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Sep 2015to 1 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- known hypersensitivity to metformin or irinotecan
- Uncontrolled Central nervous system metastasis
- Acute or chronic severe infection
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Barretos Cancer Hospital
Barretos, São Paulo, 14784-400
Joao Paulo SN Lima, MD, 551733216600 ext. 6829, joao.lima@accamargo.org.br
Arinilda C Bragagnoli, MD, 551733216600 ext. 6829, aryscampos@yahoo.com.br
- Not yet recruiting
State University of Campinas
Campinas, São Paulo, 1300000
Lígia T Macedo, MD, ligaimed@gmail.com
Ligia T Macedo, MD
About this study
Official title: Phase II Trial of Metformin Combined to Irinotecan for Refractory Metastatic or Recurrent Colorectal Cancer
MetIri seeks to identify if metformin combined to irinotecan can improve tumor control.
Read the 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.
- Conditions
- Colorectal Neoplasms, Adenocarcinoma
- Being tested
- metformin, irinotecan
- Keywords
- metformin, colorectal cancer, chemotherapy
- Medical subject headings
- Colorectal Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metforminDrug
metformin up to 2500mg/d
irinotecanDrug
Irinotecan 350 mg/m² IV q21d
| Study group | Role | What they receive |
|---|---|---|
| metfomin + irinotecan | Experimental | Irinotecan 350mg/m² q21d + metformin up to 2500mg/d until disease progression, prohibitive toxicity or consent withdrawal Receives: Drug: metformin; Drug: irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-Progression at week 12th of treatment
Non-Progression at week 12th of treatment
Measured: 12th week
Secondary outcomes (4)
Progression-free survival
Progression-free survival
Measured: 12th week
Overall Survival
Overall Survival
Measured: 12th week
Quality of life
Measured by EORTC QLQ C30
Measured: 12th week
Safety
Assessment of toxicity according to CTC 4.0
Measured: 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study start1 Sep 2015
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Campinas, Brazil, AC Camargo Cancer Center
- Responsible party
- Sponsor
- Investigators
- Joao Paulo SN Lima, MD, PhD, Principal investigator, AC Camargo Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930864
- Sponsor's protocol ID
- MetIri
- Status last verified
- Jun 2017
- First submitted
- 26 Aug 2013
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Upon data collection, the info will be put on a online database
Publications
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.
PubMed 21543517
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Metformin Combined to Irinotecan for Refractory Metastatic or Recurrent Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01930864
- Acronym / sponsor ID
- MetIri
- Conditions
- Colorectal Neoplasms, Adenocarcinoma
- Keywords
- metformin, colorectal cancer, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Collaborators
- University of Campinas, Brazil, AC Camargo Cancer Center
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 29 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| metfomin + irinotecan | Experimental | Drug: metformin, Drug: irinotecanIrinotecan 350mg/m² q21d + metformin up to 2500mg/d until disease progression, prohibitive toxicity or consent withdrawal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- known hypersensitivity to metformin or irinotecan
- Uncontrolled Central nervous system metastasis
- Acute or chronic severe infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metforminmetformin up to 2500mg/d | Drug | metfomin + irinotecan |
| irinotecanIrinotecan 350 mg/m² IV q21d | Drug | metfomin + irinotecan |
Primary outcome
Non-Progression at week 12th of treatment
Time frame: 12th week
Non-Progression at week 12th of treatment
4 secondary outcomes
Progression-free survival
Time frame: 12th week
Overall Survival
Time frame: 12th week
Quality of life
Time frame: 12th week
Safety
Time frame: 12th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Background: PubMed 21543517Rocha 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.
- Individual participant dataSharing planned: Yes. Upon data collection, the info will be put on a online database
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joao Paulo SN Lima, MD, PhD principal investigator
AC Camargo Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing metformin and irinotecan in people with Colorectal Neoplasms and Adenocarcinoma, run by Barretos Cancer Hospital at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joao Paulo SN Lima, MD (551733216600 ext. 7128, joao.lima@accamargo.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-Progression at week 12th of treatment (time frame: 12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01930864, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2017.