A Phase II Trial Of Celecoxib (Celebrex) And Capecitabine (Xeloda) Combined With Pelvic Irradiation As Neoadjuvant Treatment Of Stage II or III Adenocarcinoma Of The Rectum
- Determine the pathological complete response rate in patients with stage II or III
adenocarcinoma of the rectum treated with neoadjuvant celecoxib and capecitabine in
combination with pelvic irradiation.
- Determine the safety and tolerability of this regimen in these patients.
- Determine the rectal function of patients treated with this regimen.
- Determine the time to recurrence or progression and survival time of patients treated
with this regimen.
- Correlate cellular and molecular markers in pretreatment tumor samples with response in
patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Neoadjuvant chemoradiotherapy: Patients receive oral celecoxib twice daily on days 1-7
and oral capecitabine twice daily on days 1-5. Patients undergo pelvic radiotherapy
once daily on days 1-5. Courses repeat weekly for 5.5 weeks.
- Surgery: Patients undergo surgery 4-6 weeks after completion of neoadjuvant
- Adjuvant chemotherapy: Patients with a curative resection receive oral capecitabine
twice daily on days 1-14. Treatment repeats every 21 days for up to 4 courses.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 23-55 patients will be accrued for this study within 10-28
Masking: Open Label, Primary Purpose: Treatment
Proportion of successes
Frank Sinicrope, MD
United States: Federal Government