Metformin and 5-fluorouracil for Refractory Colorectal Cancer.

NCT01941953 | Completed Phase 2

• 1 other identifier: NP 273/12
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Colorectal Cancer

Keywords

Metformin; Metastatic Colorectal Cancer; Fluorouracil

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate according to RECIST 1.1

  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 (3)

• Progression-free Survival

  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

  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

  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.

Study Arms (1)

Metformin and Flourouracil

EXPERIMENTAL

Drug: Metformin and Fluorouracil

Interventions

Metformin and Fluorouracil DRUG

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

Metformin and Flourouracil

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

Instituto Do Cancer Do Estado de São Paulo

São Paulo, São Paulo, 01246-000, Brazil

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Metformin; Fluorouracil

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow in Clinical Oncology

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: September 13, 2013
• Study Start: November 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: March 1, 2015
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

BR (1)