Metformin and 5-fluorouracil for Refractory Colorectal Cancer. | RxWiki

Metformin and 5-fluorouracil for Refractory Colorectal Cancer.

Overview[ - collapse ][ - ]

Purpose	This is a phase II trial to evaluate efficacy and safety of Metformin and Fluorouracil in patients with metastatic colorectal cancer (CRC) who have progressed after Oxaliplatin and Irinotecan based chemotherapy.
Condition	Metastatic Colorectal Cancer
Intervention	Drug: Metformin and Fluorouracil
Phase	Phase 2
Sponsor	Instituto do Cancer do Estado de São Paulo
Responsible Party	Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier	NCT01941953
First Received	September 4, 2013
Last Updated	September 10, 2013
Last verified	September 2013

Tracking Information[ + expand ][ + ]

First Received Date	September 4, 2013
Last Updated Date	September 10, 2013
Start Date	November 2012
Estimated Primary Completion Date	November 2015
Current Primary Outcome Measures	Disease Control Rate according to RECIST 1.1 [Time Frame: From randomization of the first subject until the database cut-off approximately 12 months later (01Nov2012 up to 01Nov2015). Tumor assessed at 8 week intervals] [Designated as safety issue: No]
Current Secondary Outcome Measures	Progression-free Survival [Time Frame: From randomization of the first subject until the database cut-off approximately 12 months later (01Nov2012 up to 01Nov2015). Tumor assessed at 4 week intervals.] [Designated as safety issue: No]defined as time from randomization to death from any cause, or even radiological detection/or clinical of disease progression, increased CEA will not be considered isolated progression. Overall Survival [Time Frame: From randomization of the first subject until the database cut-off approximately 12 months later (01Nov2012 up to 01Nov2015). Tumor assessed at 4 week intervals] [Designated as safety issue: No]defined as time from first dose of treatment until death, with date of last visit being considered censorship Adverse Events [Time Frame: From randomization of the first subject until the database cut-off approximately 12 months later (01Nov2012 up to 01Nov2015). Tumor assessed at 4 week intervals.] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Metformin and 5-fluorouracil for Refractory Colorectal Cancer.
Official Title	Phase II Study of Metformin and 5-fluorouracil in Patients With Advanced Colorectal Cancer Previously Treated With Oxaliplatin and Irinotecan Based Chemotherapy.
Brief Summary	This is a phase II trial to evaluate efficacy and safety of Metformin and Fluorouracil in patients with metastatic colorectal cancer (CRC) who have progressed after Oxaliplatin and Irinotecan based chemotherapy.
Detailed Description	Primary Outcomes Measures: - Disease control Rate at 8 weeks according to RECIST 1.1 (Tumor response was defined as the percentage of patients with complete response, partial response or stable disease as best overall response). Secondary Outcome Measures: - Progression-free Survival - Overall Survival - Adverse Events (assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0)
Study Type	Interventional
Study Phase	Phase 2
Study Design	Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Metastatic Colorectal Cancer
Intervention	Drug: Metformin and Fluorouracil metformin 850mg PO BID plus 5FU 425mg/m2 + leucovorin 50mg IV weekly
Study Arm (s)	Experimental: Metformin and Flourouracil

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	45
Estimated Completion Date	November 2015
Estimated Primary Completion Date	November 2014
Eligibility Criteria	Inclusion Criteria - Histological diagnosis of metastatic colorectal adenocarcioma previously treated with at least two lines of chemotherapy (oxaliplatin and irinotecan regimens) if mutated KRAS or treated with at least 3 lines of chemotherapy (oxaliplatin, irinotecan and cetuximab) if KRAS wild type. - Disease progression according to radiological or clinical assessment. - Measurable disease. - ECOG Performance 0-1. - Age above 16 years. - Normal organic function as defined for the following criteria: - Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 times the upper normal limit of the local laboratory (LSN-LL); - Total serum bilirubin ≤ 2.0 x ULN-LL; - Absolute neutrophil count ≥ 1,500 / mm3; - Platelet count ≥ 100,000 / mm3; - Hemoglobin ≥ 8.0 g / dl; - Serum creatinine ≤ 1.5 x ULN-LL - Written informed consent before enrollment Exclusion Criteria - Diabetic patients taking metformin. - Patients already treated with mTOR inhibitors. - Hypersensitivity to metformin, renal or hepatic impairment or other conditions that predispose to lactic acidosis. - History of acute myocardial infarction in the last 6 months - Serious illness or psychiatric condition. - Current participation in other protocols with experimental drugs. - Suspicion of dihidropirimida dehydrogenase(DPD)deficiency. - Presence of active infection. - No ability to ingest food orally. - Patients with metastatic disease to CNS. - Patients who underwent major surgery in the last 4 weeks. - Patients who received chemotherapy in the last three weeks. - Patients who underwent radiotherapy in the last 2 weeks or who received radiotherapy in the target lesion, if this is the only target lesion. - Patients using oral anticoagulation (warfarin). - Pregnant or lactating patients
Gender	Both
Ages	16 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Vanessa C Miranda, MD +551138932686
Location Countries	Brazil

Administrative Information[ + expand ][ + ]

NCT Number	NCT01941953
Other Study ID Numbers	NP 273/12
Has Data Monitoring Committee	No
Information Provided By	Instituto do Cancer do Estado de São Paulo
Study Sponsor	Instituto do Cancer do Estado de São Paulo
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	September 2013

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