Oxaliplatin and Docetaxel for Recurrent or Metastatic Head and Neck Cancer
|Neoplasms Head and Neck Neoplasms||Drug: Oxaliplatin and Docetaxel||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter Phase II Trial of Oxaliplatin and Docetaxel for Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck|
- Response rate as determined by RECIST criteria every 6 weeks. [ Time Frame: 2 Years ]
- Toxicity and Quality of Life assessments every 3 weeks. [ Time Frame: 2 years ]
|Study Start Date:||April 2005|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
This is a single arm trial.
Drug: Oxaliplatin and Docetaxel
Oxaliplatin 130mg/m2 on day 1; and Docetaxel 75mg/m2 on day 1; every 21 days.
Oxaliplatin: 130mg/m2 given on day 1 by intravenous injection; and Docetaxel: 60mg/m2 given on day 1 by intravenous injection
Cycles are repeated every 21 days until disease progression, unacceptable toxicity or subject's withdrawal.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00557206
|United States, Minnesota|
|VA Medical Center|
|Minneapolis, Minnesota, United States, 55417|
|Principal Investigator:||Balkrishna Jahagirdar, MD||Minneapolis Veterans Affairs Medical Center|
|Principal Investigator:||Vicki A Morrison, MD||Minneapolis Veterans Affairs Medical Center|