A Phase II Study of Capecitabine (Xeloda)/Oxaliplatin (Eloxatin) With Concomitant Radiotherapy (XRT), XELOX/RT in Squamous Cell Carcinoma of the Anal Canal
OBJECTIVES:
Primary
- Determine time to treatment failure in patients with stage II-IIIB squamous cell
carcinoma of the anal canal treated with capecitabine, oxaliplatin, and radiotherapy.
- Determine the toxic effects of this regimen in these patients.
Secondary
- Determine the complete response rate in patients treated with this regimen.
- Determine 2-year local regional control in patients treated with this regimen.
- Determine 2-year colostomy-free survival in patients treated with this regimen.
- Determine 2-year median overall survival in patients treated with this regimen.
- Determine 2-year progression-free survival in patients treated with this regimen.
OUTLINE: Patients receive oral capecitabine* twice daily on days 1-2, 6-10, 20-24, 27-31,
and 41-42, and undergo radiotherapy* once daily on days 1-3, 6-10, 13-17, 20-24, 27-31,
34-38, and 41-42. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 22, and
29. Treatment continues in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients with T3-4 lesions also receive oral capecitabine twice daily and undergo
radiotherapy once daily on days 43 and 44.
Patients are followed at 4-6 and 12 weeks and then periodically thereafter.
PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to Treatment Failure
3 Months
No
Cathy Eng, MD
Study Chair
M.D. Anderson Cancer Center
United States: Food and Drug Administration
2003-0874
NCT00093379
April 2004
July 2012
Name | Location |
---|---|
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |