Metformin Plus Irinotecan for Refractory Colorectal Cancer
NCT ID: NCT01930864
Last Updated: 2017-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
41 participants
INTERVENTIONAL
2015-09-01
2020-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Neoadjuvant Metformin in Association to Chemoradiotherapy for Locally Advanced Rectal Cancer
NCT02473094
Trial of Metformin for Colorectal Cancer Risk Reduction for History of Colorectal Adenomas and Elevated BMI
NCT01312467
Metformin With Neoadjuvant Chemoradiation to Improve Pathologic Responses in Rectal Cancer
NCT03053544
Study of Blood Components as Probable Prognostic and Predictive Markers of Response to Treatment in Advanced Colon and Rectal Cancers
NCT02979470
Cetuximab Plus Irinotecan in Patients With NeoRAS Wild-type Metastatic Colorectal Cancer In Third-line Therapy
NCT05962502
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
metfomin + irinotecan
Irinotecan 350mg/m² q21d + metformin up to 2500mg/d until disease progression, prohibitive toxicity or consent withdrawal
metformin
metformin up to 2500mg/d
irinotecan
Irinotecan 350 mg/m² IV q21d
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
metformin
metformin up to 2500mg/d
irinotecan
Irinotecan 350 mg/m² IV q21d
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Uncontrolled Central nervous system metastasis
* Acute or chronic severe infection
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Campinas, Brazil
OTHER
AC Camargo Cancer Center
OTHER
Barretos Cancer Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joao Paulo SN Lima, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
AC Camargo Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Barretos Cancer Hospital
Barretos, São Paulo, Brazil
State University of Campinas
Campinas, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MetIri
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.