Metastatic Colorectal CancerPhase 2NCT01941953
Metformin and 5-fluorouracil for Refractory Colorectal Cancer.
A Phase 2 study testing Metformin and Fluorouracil in people with Metastatic Colorectal Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Metformin and Fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2012to Mar 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto Do Cancer Do Estado de São Paulo
São Paulo, São Paulo, 01246-000
About this study
Official title: Phase II Study of Metformin and 5-fluorouracil in Patients With Advanced Colorectal Cancer Previously Treated With Oxaliplatin and Irinotecan Based Chemotherapy.
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.
Read the 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)
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Metformin and Fluorouracil
- Keywords
- Metformin, Metastatic Colorectal Cancer, Fluorouracil
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin and FluorouracilDrug
metformin 850mg PO BID plus 5FU 425mg/m2 + leucovorin 50mg IV weekly
| Study group | Role | What they receive |
|---|---|---|
| Metformin and Flourouracil | Experimental | Not described Receives: Drug: Metformin and Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate according to RECIST 1.1
Measured: 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
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.
Measured: 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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startNov 2012
- Primary completionNov 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanessa C Miranda, Instituto do Cancer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941953
- Sponsor's protocol ID
- NP 273/12
- Status last verified
- Apr 2015
- First submitted
- 4 Sep 2013
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Metformin and 5-fluorouracil in Patients With Advanced Colorectal Cancer Previously Treated With Oxaliplatin and Irinotecan Based Chemotherapy.
- ClinicalTrials.gov ID
- NCT01941953
- Acronym / sponsor ID
- NP 273/12
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Metformin, Metastatic Colorectal Cancer, Fluorouracil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metformin and Flourouracil | Experimental | Drug: Metformin and Fluorouracil |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin and Fluorouracilmetformin 850mg PO BID plus 5FU 425mg/m2 + leucovorin 50mg IV weekly | Drug | Metformin and Flourouracil |
Primary outcome
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
3 secondary outcomes
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin and Fluorouracil in people with Metastatic Colorectal Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015.