Head and Neck Neoplasms Clinical Trial
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
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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