Metformin Plus Paclitaxel for Metastatic or Recurrent Head and Neck Cancer

• Status: Terminated
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lucas Vieira dos Santos
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo; University of Campinas, Brazil
• Treatments: Albumin-Bound Paclitaxel; Metformin; Paclitaxel

Criteria

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