Metformin Plus Paclitaxel for Metastatic or Recurrent Head and Neck Cancer

NCT01333852 | Terminated Phase 2 DMC

• 1 other identifier: METTAX200901
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma

Keywords

head and neck cancer; paclitaxel; metformin; squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (2)

Paclitaxel, placebo

ACTIVE COMPARATOR

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

Drug: paclitaxel 175mg/m² q21d; Drug: placebo

Paclitaxel plus metformin

EXPERIMENTAL

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

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

Interventions

metformin up to 2500mg/d DRUG

metformin up to 2500mg/d

Also known as: Glifage

Paclitaxel plus metformin

paclitaxel 175mg/m² q21d DRUG

paclitaxel 175mg/m² q21d

Also known as: taxol

Paclitaxel plus metformin; Paclitaxel, placebo

placebo DRUG

placebo

Paclitaxel, placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• known hypersensitivity to metformin or paclitaxel
• SNC metastasis
• Acute or chronic infection

Sponsors & Collaborators

• Lucas Vieira dos Santos: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• University of Campinas, Brazil: collaborator

Study Sites (1)

Barretos Cancer Hospital

Barretos, São Paulo, 14784400, Brazil

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Lucas V dos Santos, MD

  HCB

  PRINCIPAL INVESTIGATOR

• Jose BC Carvalheira, MD, PhD

  University of Campinas, Brazil

  STUDY CHAIR

• Andre L. Carvalho, MD, PhD

  HCB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 5, 2011
• First Posted: April 12, 2011
• Study Start: February 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: April 1, 2014
• Last Updated: January 27, 2015

Record last verified: 2015-01

Locations

BR (1)