Metformin Plus Paclitaxel for Metastatic or Recurrent Head and Neck Cancer (METTAX)

Lucas Vieira dos Santos

Status and phase: Terminated; Phase 2

Conditions: Squamous Cell Carcinoma; Head and Neck Neoplasms

Treatments: Drug: metformin up to 2500mg/d; Drug: paclitaxel 175mg/m² q21d; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01333852

METTAX200901

Details and patient eligibility

About

Metformin plus paclitaxel for recurrent or metastatic head and neck cancer: a randomized phase II trial

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 2 patient groups

Paclitaxel, placebo

Active Comparator group

Description:

Paclitaxel 175mg/m² q21d until disease progression, unacceptable toxicity or consent withdrawal

Treatment:

Drug: placebo

Drug: paclitaxel 175mg/m² q21d

Paclitaxel plus metformin

Experimental group

Description:

Paclitaxel 175mg/m² q21d + metformin up to 2500mg/d until disease progression, prohibitive toxicity or consent withdrawal

Treatment:

Drug: paclitaxel 175mg/m² q21d

Drug: metformin up to 2500mg/d