NCT00266279

Phase II (Treatment) Study of Oxaliplatin and Capecitabine in Advanced Head and Neck Malignancies

Phase II Study of Oxaliplatin and Capecitabine in Advanced Head and Neck Malignancies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II study will test the response rate of combined oxaliplatin and capecitabine treatment when administered at a given dose and schedule, in patients with Head and Neck cancer for which there is no curative treatment.

Detailed description

The optimal dose and schedule for the combined treatment with oxaliplatin and capecitabine have not been defined. The aim of this Phase II study is to determine the response rate of combined oxaliplatin and capecitabine treatment at a given dose and schedule in patients with Head and Neck cancer for which there is no curative treatment. The study also aims to determine the qualitative and quantitative toxicity and reversibility of toxicity of the above combination and to evaluate any changes in performance status, quality of life, overall survival and progression-free survival.

Conditions

• Head or Neck Cancer

Interventions

Type	Name	Description
DRUG	Oxaliplatin, Capecitabine	Agent, DOSE AND SCHEDULE (28-days cycle): Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21

Timeline

• Start date: 2005-04-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2005-12-16
• Last updated: 2020-09-03
• Results posted: 2014-10-31

Locations

1 site across 1 country: United States