Oxaliplatin and Capecitabine in Treating Patients With Relapsed or Metastatic Head and Neck Cancer
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Relapsed or Metastatic Head and Neck Carcinomas With Oxaliplatin and Capecitabine|
- Objective response rate (complete response and partial response) [ Designated as safety issue: No ]
- Toxicity as measured by NCI CTC [ Designated as safety issue: Yes ]
- Survival [ Designated as safety issue: No ]
|Study Start Date:||February 2004|
|Study Completion Date:||June 2008|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|