Randomized Phase II Study of Paclitaxel Plus Metformin or Placebo for the Treatment of Platinum-refractory, Recurrent or Metastatic Head and Neck Neoplasms
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Disease control at week 12
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Paclitaxel plus metformin
Paclitaxel 175mg/m² q21d + metformin up to 2500mg/d until disease progression, prohibitive toxicity or consent withdrawal
Intervention: metformin up to 2500mg/d (Drug)
Paclitaxel, placebo
Paclitaxel 175mg/m² q21d until disease progression, unacceptable toxicity or consent withdrawal
Intervention: paclitaxel 175mg/m² q21d (Drug)
Paclitaxel plus metformin
Paclitaxel 175mg/m² q21d + metformin up to 2500mg/d until disease progression, prohibitive toxicity or consent withdrawal
Intervention: paclitaxel 175mg/m² q21d (Drug)
Paclitaxel, placebo
Paclitaxel 175mg/m² q21d until disease progression, unacceptable toxicity or consent withdrawal
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Progression-free survival(6mo after the last patient recruited)
- Overall Survival (subjects without death (any cause))(6mo after the last enrolled patient)
- Number of patients with Grade 3-5 Adverse Events in each arm, for each category of AE(6 mo after the last enrolled patients)
Investigators
Lucas Vieira dos Santos
Dr
Barretos Cancer Hospital