Metformin Plus Paclitaxel for Metastatic or Recurrent Head and Neck Cancer (METTAX)
|Head and Neck Neoplasms Squamous Cell Carcinoma||Drug: metformin up to 2500mg/d Drug: paclitaxel 175mg/m² q21d Drug: placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- 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.
- Progression-free survival [ Time Frame: 6mo after the last patient recruited ]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.
- Overall Survival (subjects without death (any cause)) [ Time Frame: 6mo after the last enrolled patient ]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.
- 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 ]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.
|Study Start Date:||February 2011|
|Study Completion Date:||April 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Paclitaxel, placebo
Paclitaxel 175mg/m² q21d until disease progression, unacceptable toxicity or consent withdrawal
Drug: paclitaxel 175mg/m² q21d
paclitaxel 175mg/m² q21d
Other Name: taxolDrug: placebo
Experimental: Paclitaxel plus metformin
Paclitaxel 175mg/m² q21d + metformin up to 2500mg/d until disease progression, prohibitive toxicity or consent withdrawal
Drug: metformin up to 2500mg/d
metformin up to 2500mg/d
Other Name: GlifageDrug: paclitaxel 175mg/m² q21d
paclitaxel 175mg/m² q21d
Other Name: taxol
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333852
|Barretos Cancer Hospital|
|Barretos, SP, Brazil, 14784400|
|Principal Investigator:||Lucas V dos Santos, MD||HCB|
|Study Chair:||Jose BC Carvalheira, MD, PhD||University of Campinas, Brazil|
|Study Director:||Andre L. Carvalho, MD, PhD||HCB|