Metformin and 5-fluorouracil for Refractory Colorectal Cancer.

Phase 2CompletedNCT01941953

Instituto do Cancer do Estado de São Paulo50 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Colorectal Cancer

Interventions

Metformin and FluorouracilDRUG

metformin 850mg PO BID plus 5FU 425mg/m2 + leucovorin 50mg IV weekly

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Instituto Do Cancer Do Estado de São Paulo

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

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

Secondary Outcomes

Progression-free Survival

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.

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.

Overall Survival

defined as time from first dose of treatment until death, with date of last visit being considered censorship

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

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.

Data from ClinicalTrials.gov

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