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Metformin and 5-fluorouracil for Refractory Colorectal Cancer.

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ClinicalTrials.gov Identifier: NCT01941953
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : April 8, 2015
Sponsor:
Information provided by (Responsible Party):
Vanessa C Miranda, Instituto do Cancer do Estado de São Paulo

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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Metformin and Fluorouracil Phase 2

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Metformin and 5-fluorouracil in Patients With Advanced Colorectal Cancer Previously Treated With Oxaliplatin and Irinotecan Based Chemotherapy.
Study Start Date : November 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Metformin and Flourouracil Drug: Metformin and Fluorouracil
metformin 850mg PO BID plus 5FU 425mg/m2 + leucovorin 50mg IV weekly




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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. ]
    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.

  2. 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 ]
    defined as time from first dose of treatment until death, with date of last visit being considered censorship

  3. 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. ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941953


Locations
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Brazil
Instituto Do Cancer Do Estado de São Paulo
Sao Paulo, Brazil, 01246-000
Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo

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Responsible Party: Vanessa C Miranda, Fellow in Clinical Oncology, Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT01941953     History of Changes
Other Study ID Numbers: NP 273/12
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015
Keywords provided by Vanessa C Miranda, Instituto do Cancer do Estado de São Paulo:
Metformin
Metastatic Colorectal Cancer
Fluorouracil
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Metformin
Fluorouracil
Hypoglycemic Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors