Metformin Plus Irinotecan for Refractory Colorectal Cancer
Overview[ - collapse ][ - ]
| Purpose | MetIri seeks to identify if metformin combined to irinotecan can improve tumor control. |
|---|---|
| Condition | Colorectal Neoplasms Adenocarcinoma |
| Intervention | Drug: Metformin Drug: Irinotecan |
| Phase | Phase 2 |
| Sponsor | Barretos Cancer Hospital |
| Responsible Party | Barretos Cancer Hospital |
| ClinicalTrials.gov Identifier | NCT01930864 |
| First Received | August 26, 2013 |
| Last Updated | April 17, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 26, 2013 |
|---|---|
| Last Updated Date | April 17, 2014 |
| Start Date | April 2014 |
| Estimated Primary Completion Date | September 2015 |
| Current Primary Outcome Measures | Non-Progression at week 12th of treatment [Time Frame: 12th week] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Metformin Plus Irinotecan for Refractory Colorectal Cancer |
|---|---|
| Official Title | Phase II Trial of Metformin Combined to Irinotecan for Refractory Metastatic or Recurrent Colorectal Cancer |
| 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 anti-EGFr antibody if Kras wild type. |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition |
|
| Intervention | Drug: Metformin metformin up to 2500mg/d Drug: Irinotecan Irinotecan 350 mg/m² IV q21d |
| Study Arm (s) | Experimental: Metfomin + irinotecan Irinotecan 350mg/m² q21d + metformin up to 2500mg/d until disease progression, prohibitive toxicity or consent withdrawal |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Not yet recruiting |
|---|---|
| Estimated Enrollment | 41 |
| Estimated Completion Date | September 2015 |
| Estimated Primary Completion Date | September 2015 |
| 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 - SNC metastasis - Acute or chronic severe infection |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Joao Paulo SN Lima, MD 551733216600 jpsnlima@yahoo.com.br |
| Location Countries | Brazil |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01930864 |
|---|---|
| Other Study ID Numbers | MetIri |
| Has Data Monitoring Committee | No |
| Information Provided By | Barretos Cancer Hospital |
| Study Sponsor | Barretos Cancer Hospital |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Joao Paulo SN Lima, MD, PhD Barretos Cancer Hospital |
| Verification Date | April 2014 |
Locations[ + expand ][ + ]
| Barretos Cancer Hospital | Barretos, SP, Brazil, 14784-400 Contact: Joao Paulo SN Lima, MD | 5517332166007128 | joaopaulo.oncologia@hcancerbarretos.com.brPrincipal Investigator: Joao Paulo SN Lima, MD, PhD Recruiting |
|---|---|
| State University of Campinas | Campinas, São Paulo, Brazil, 1300000 Contact: Lígia T Macedo, MD | ligaimed@gmail.comPrincipal Investigator: Ligia T Macedo, MD Not yet recruiting |