Metformin Plus Paclitaxel for Metastatic or Recurrent Head and Neck Cancer

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• known hypersensitivity to metformin or paclitaxel
• SNC metastasis
• Acute or chronic infection