Head and Neck NeoplasmsPhase 2METTAXNCT01333852
Metformin Plus Paclitaxel for Metastatic or Recurrent Head and Neck Cancer
A Phase 2 study testing metformin up to 2500mg/d and paclitaxel 175mg/m² q21d in people with Head and Neck Neoplasms and Squamous Cell Carcinoma, run by Lucas Vieira dos Santos at 1 site in Brazil.
Trial summary
Metformin plus paclitaxel for recurrent or metastatic head and neck cancer: a randomized phase II trial Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Squamous Cell Carcinoma
- What is being tested?
- metformin up to 2500mg/d and paclitaxel 175mg/m² q21d
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2011to Apr 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Biopsy-proven head and neck squamous cell carcinoma
- Ineligibility for curative intent therapy, e.g., surgery or radiation therapy
- recurrent or stage IV disease
- previous failure to platinum-based chemotherapy
- measurable disease according to RECIST v1.1
- PS ECOG 0-2
Who cannot join
- known hypersensitivity to metformin or paclitaxel
- SNC metastasis
- Acute or chronic infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase II Study of Paclitaxel Plus Metformin or Placebo for the Treatment of Platinum-refractory, Recurrent or Metastatic Head and Neck Neoplasms
Metformin plus paclitaxel for recurrent or metastatic head and neck cancer: a randomized phase II trial
Read the detailed description
METTAX is a phase II randomized trial that aim to evaluate the addition of metformin to paclitaxel in patients that failed to curative-intent treatment for Head-and neck neoplasms.
Patients eligible for this protocol will be randomized to paclitaxel 175mg/m2 plus metformin or placebo until disease progression or unacceptable toxicity. The primary end-point is disease control (complete response, partial response or stable disease, according to RECIST 1.1) in the 12th week. Secondary end-points are PFS, OS, response rate and safety. Molecular markers in samples collected before and under treatment will be tested for correlation with clinical outcomes.
- Conditions
- Head and Neck Neoplasms, Squamous Cell Carcinoma
- Being tested
- metformin up to 2500mg/d, paclitaxel 175mg/m² q21d, placebo
- Keywords
- head and neck cancer, paclitaxel, metformin, squamous cell carcinoma
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metformin up to 2500mg/dDrug
Also called Glifage
metformin up to 2500mg/d
paclitaxel 175mg/m² q21dDrug
Also called taxol
paclitaxel 175mg/m² q21d
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel, placebo | Active comparator | Paclitaxel 175mg/m² q21d until disease progression, unacceptable toxicity or consent withdrawal Receives: Drug: paclitaxel 175mg/m² q21d; Drug: placebo |
| Paclitaxel plus metformin | Experimental | Paclitaxel 175mg/m² q21d + metformin up to 2500mg/d until disease progression, prohibitive toxicity or consent withdrawal Receives: Drug: metformin up to 2500mg/d; Drug: paclitaxel 175mg/m² q21d |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control at week 12
Number of subjects at week 12 with complete response, partial response or stable disease, over the total number of subjects, for each arm. Disease control means complete response, partial response or stable disease, according to RECIST 1.1.
Measured: 12th week
Secondary outcomes (3)
Progression-free survival
We will measure the number of subjects without progressive disease (complete response, partial response or stable disease) 6mo after the start of therapy, also after 1 and 2 years from the start of therapy. PFS will also be analysed with log-rank test, and reported as HR with respective 95% CI and p value, and median PFS will be estimated with kaplan-meyer method. All calculations will be performed 6 months after the last patient recruited. Also, the survival rate at year one and two will be calculated.
Measured: 6mo after the last patient recruited
Overall Survival (subjects without death (any cause))
We will measure the number of subjects without death (any cause) 6mo after the start of therapy, and also after 1 and 2 years from the start of therapy. OS will also be analysed with log-rank test, and reported as HR with respective 95% CI and p value, and median OS will be estimated with kaplan-meyer method. All calculations will be performed 6 months after the last patient recruited. Also, the survival rate at year one and two will be calculated.
Measured: 6mo after the last enrolled patient
Number of patients with Grade 3-5 Adverse Events in each arm, for each category of AE
Safety and tolerability will be assessed using NCI CTCAE v3. The number of patients in each arm experiencing grade 3-5 AE (for each AE) over the total number of subjects will be measured, and the proportion of patients experiencing AE in each arm will be compared using uncorrected chi-sq test. AE will be recorded in baseline and in each visit, and the worst grade AE will be considered.
Measured: 6 mo after the last enrolled patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startFeb 2011
- Primary completionJan 2014
- Study completionApr 2014
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lucas Vieira dos Santos
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, University of Campinas, Brazil
- Responsible party
- Sponsor-investigator, Lucas Vieira dos Santos, Barretos Cancer Hospital
- Investigators
- Lucas V dos Santos, MD, Principal investigator, HCBJose BC Carvalheira, MD, PhD, Study chair, University of Campinas, BrazilAndre L. Carvalho, MD, PhD, Study director, HCB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333852
- Sponsor's protocol ID
- METTAX200901
- Acronym
- METTAX
- Status last verified
- Jan 2015
- First submitted
- 5 Apr 2011
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of Paclitaxel Plus Metformin or Placebo for the Treatment of Platinum-refractory, Recurrent or Metastatic Head and Neck Neoplasms
- ClinicalTrials.gov ID
- NCT01333852
- Acronym / sponsor ID
- METTAX / METTAX200901
- Conditions
- Head and Neck Neoplasms, Squamous Cell Carcinoma
- Keywords
- head and neck cancer, paclitaxel, metformin, squamous cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Lucas Vieira dos SantosUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, University of Campinas, Brazil
- Study start
- Feb 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 12 Apr 2011 (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.
Metformin plus paclitaxel for recurrent or metastatic head and neck cancer: a randomized phase II trial
Detailed description
METTAX is a phase II randomized trial that aim to evaluate the addition of metformin to paclitaxel in patients that failed to curative-intent treatment for Head-and neck neoplasms.
Patients eligible for this protocol will be randomized to paclitaxel 175mg/m2 plus metformin or placebo until disease progression or unacceptable toxicity. The primary end-point is disease control (complete response, partial response or stable disease, according to RECIST 1.1) in the 12th week. Secondary end-points are PFS, OS, response rate and safety. Molecular markers in samples collected before and under treatment will be tested for correlation with clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel, placebo | Active comparator | Drug: paclitaxel 175mg/m² q21d, Drug: placeboPaclitaxel 175mg/m² q21d until disease progression, unacceptable toxicity or consent withdrawal |
| Paclitaxel plus metformin | Experimental | Drug: metformin up to 2500mg/d, Drug: paclitaxel 175mg/m² q21dPaclitaxel 175mg/m² q21d + metformin up to 2500mg/d until disease progression, prohibitive toxicity or consent withdrawal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years or older
- Biopsy-proven head and neck squamous cell carcinoma
- Ineligibility for curative intent therapy, e.g., surgery or radiation therapy
- recurrent or stage IV disease
- previous failure to platinum-based chemotherapy
Key exclusion criteria (3 listed)
- known hypersensitivity to metformin or paclitaxel
- SNC metastasis
- Acute or chronic infection
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 up to 2500mg/dAlso: Glifagemetformin up to 2500mg/d | Drug | Paclitaxel plus metformin |
| paclitaxel 175mg/m² q21dAlso: taxolpaclitaxel 175mg/m² q21d | Drug | Paclitaxel plus metformin, Paclitaxel, placebo |
| placeboplacebo | Drug | Paclitaxel, placebo |
Primary outcome
Disease control at week 12
Time frame: 12th week
Number of subjects at week 12 with complete response, partial response or stable disease, over the total number of subjects, for each arm. Disease control means complete response, partial response or stable disease, according to RECIST 1.1.
3 secondary outcomes
Progression-free survival
Time frame: 6mo after the last patient recruited
Overall Survival (subjects without death (any cause))
Time frame: 6mo after the last enrolled patient
Number of patients with Grade 3-5 Adverse Events in each arm, for each category of AE
Time frame: 6 mo after the last enrolled patients
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 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.
Lucas V dos Santos, MD principal investigator
HCB
Jose BC Carvalheira, MD, PhD study chair
University of Campinas, Brazil
Andre L. Carvalho, MD, PhD study director
HCB
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 up to 2500mg/d and paclitaxel 175mg/m² q21d in people with Head and Neck Neoplasms and Squamous Cell Carcinoma, run by Lucas Vieira dos Santos 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 7 inclusion and 3 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: stopped early, as of the sponsor's last update on 27 Jan 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 was stopped early (reason given: Low accrual). Results are not available in the source record.
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 at week 12 (time frame: 12th week). 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 27 Jan 2015.