Metformin and 5-fluorouracil for Refractory Colorectal Cancer.

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto do Cancer do Estado de São Paulo
• Treatments: Fluorouracil; Metformin

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