Oxaliplatin and Docetaxel for Recurrent or Metastatic Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00557206|
Recruitment Status : Terminated (Funding was terminated)
First Posted : November 12, 2007
Last Update Posted : November 5, 2013
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms Head and Neck Neoplasms||Drug: Oxaliplatin and Docetaxel||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Phase II Trial of Oxaliplatin and Docetaxel for Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||November 2009|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|