Oxaliplatin and Capecitabine in Treating Patients With Relapsed or Metastatic Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00448552|
Recruitment Status : Completed
First Posted : March 19, 2007
Last Update Posted : December 15, 2016
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving oxaliplatin together with capecitabine works in treating patients with relapsed or metastatic head and neck cancer.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: capecitabine Drug: oxaliplatin||Phase 2|
- Determine the objective response rate in patients with chemotherapy naïve relapsed or metastatic head and neck cancer treated with oxaliplatin and capecitabine.
- Evaluate the safety and toxicity of this regimen in these patients.
- Determine the one-year survival and overall survival of these patients.
OUTLINE: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 2-15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Relapsed or Metastatic Head and Neck Carcinomas With Oxaliplatin and Capecitabine|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||June 2008|
- Objective response rate (complete response and partial response)
- Toxicity as measured by NCI CTC
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): NCT00448552
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center|
|Miami, Florida, United States, 33136|
|Study Chair:||Luis E. Raez, MD, FACP||University of Miami Sylvester Comprehensive Cancer Center|