NCT01333852

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Lucas Vieira dos Santos · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Head and Neck Neoplasms
• Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	metformin up to 2500mg/d	metformin up to 2500mg/d
DRUG	paclitaxel 175mg/m² q21d	paclitaxel 175mg/m² q21d
DRUG	placebo	placebo

Timeline

• Start date: 2011-02-01
• Primary completion: 2014-01-01
• Completion: 2014-04-01
• First posted: 2011-04-12
• Last updated: 2015-01-27

Locations

1 site across 1 country: Brazil