Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448552
Status:
COMPLETED
Last Update Posted:
2016-12-15
First Post:
2007-03-15
Brief Title:
Oxaliplatin and Capecitabine in Treating Patients With Relapsed or Metastatic Head and Neck Cancer
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
Treatment of Relapsed or Metastatic Head and Neck Carcinomas With Oxaliplatin and Capecitabine
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
Primary
Determine the objective response rate in patients with chemotherapy naïve relapsed or metastatic head and neck cancer treated with oxaliplatin and capecitabine
Secondary
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
Primary
Determine the objective response rate in patients with chemotherapy naïve relapsed or metastatic head and neck cancer treated with oxaliplatin and capecitabine
Secondary
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SCCC-2003050 | OTHER | None | None |
| WIRB-20060071 | OTHER | Western Institutional Review Board | None |