Neoadjuvant Celecoxib and Capecitabine Combined With Pelvic Irradiation in Treating Patients With Stage II or Stage III Adenocarcinoma (Cancer) of the Rectum
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Celecoxib may also make tumor cells more sensitive to chemotherapy and radiation therapy. Giving celecoxib with capecitabine and radiation therapy before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well giving neoadjuvant celecoxib together with capecitabine and pelvic irradiation works in treating patients with stage II or stage III adenocarcinoma (cancer) of the rectum.
Procedure: adjuvant therapy
Procedure: neoadjuvant therapy
Radiation: radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Proportion of successes [ Designated as safety issue: No ]
- Survival time [ Designated as safety issue: No ]
- Time-to event analyses [ Designated as safety issue: No ]
- Time to disease progression/recurrence [ Designated as safety issue: No ]
- Time to recurrence [ Designated as safety issue: No ]
- Time to first progression [ Designated as safety issue: No ]
- Survival [ Designated as safety issue: No ]
- Bowel function as measured by the Patient Bowel Function (Uniscale) Questionnaire, the FACT Diarrhea Subscale and the Mayo Bowel Function Questionnaire [ Designated as safety issue: No ]
|Study Start Date:||December 2004|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
- 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 chemoradiotherapy.
- 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 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00081224
|Study Chair:||Frank Sinicrope, MD||Mayo Clinic|
|Investigator:||James A. Martenson, MD||Mayo Clinic|
|Investigator:||Richard L. Deming, MD||Mercy Therapeutic Radiology Associates, PC at Mercy Medical Center - Des Moines|
|Investigator:||Heidi Nelson, MD||Mayo Clinic|
|Investigator:||James D. Bearden, MD||CCOP - Upstate Carolina|