Metformin Plus Paclitaxel for Metastatic or Recurrent Head and Neck Cancer

Head and Neck Neoplasms Clinical Trial

— METTAX  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01333852
• Other study ID #: METTAX200901
• Status: Terminated
• Phase: Phase 2
• First received: April 5, 2011
• Last updated: January 26, 2015
• Start date: February 2011
• Est. completion date: April 2014

Study information

• Verified date: January 2015
• Source: Barretos Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: April 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Squamous Cell Carcinoma

Intervention

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

Locations

Country	Name	City	State
Brazil	Barretos Cancer Hospital	Barretos	SP

Sponsors (3)

Lead Sponsor	Collaborator
Lucas Vieira dos Santos	Fundação de Amparo à Pesquisa do Estado de São Paulo, University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease control at week 12	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.	12th week	No
Secondary	Progression-free survival	We will measure the number of subjects without progressive disease (complete response, partial response or stable disease) 6mo after the start of therapy, also after 1 and 2 years from the start of therapy. PFS will also be analysed with log-rank test, and reported as HR with respective 95% CI and p value, and median PFS will be estimated with kaplan-meyer method. All calculations will be performed 6 months after the last patient recruited. Also, the survival rate at year one and two will be calculated.	6mo after the last patient recruited	No
Secondary	Overall Survival (subjects without death (any cause))	We will measure the number of subjects without death (any cause) 6mo after the start of therapy, and also after 1 and 2 years from the start of therapy. OS will also be analysed with log-rank test, and reported as HR with respective 95% CI and p value, and median OS will be estimated with kaplan-meyer method. All calculations will be performed 6 months after the last patient recruited. Also, the survival rate at year one and two will be calculated.	6mo after the last enrolled patient	No
Secondary	Number of patients with Grade 3-5 Adverse Events in each arm, for each category of AE	Safety and tolerability will be assessed using NCI CTCAE v3. The number of patients in each arm experiencing grade 3-5 AE (for each AE) over the total number of subjects will be measured, and the proportion of patients experiencing AE in each arm will be compared using uncorrected chi-sq test. AE will be recorded in baseline and in each visit, and the worst grade AE will be considered.	6 mo after the last enrolled patients	Yes