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Randomized Phase II Study of Paclitaxel Plus Metformin or Placebo for the Treatment of Platinum-refractory, Recurrent or Metastatic Head and Neck Neoplasms


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Neoplasms, Squamous Cell Carcinoma

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Trial Information

Randomized Phase II Study of Paclitaxel Plus Metformin or Placebo for the Treatment of Platinum-refractory, Recurrent or Metastatic Head and Neck Neoplasms


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Disease control at week 12

Outcome Description:

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.

Outcome Time Frame:

12th week

Safety Issue:

No

Principal Investigator

Lucas V dos Santos, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

HCB

Authority:

Brazil: National Committee of Ethics in Research

Study ID:

METTAX200901

NCT ID:

NCT01333852

Start Date:

February 2011

Completion Date:

July 2014

Related Keywords:

  • Head and Neck Neoplasms
  • Squamous Cell Carcinoma
  • head and neck cancer
  • paclitaxel
  • metformin
  • squamous cell carcinoma
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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