A Phase 2 interventional study of celecoxib and fluorouracil in Colorectal Cancer, sponsored by Vanderbilt-Ingram Cancer Center. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-05.
Sponsored by Vanderbilt-Ingram Cancer Center · Phase 2, Interventional, and Treatment
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Celecoxib may make tumor cells more sensitive to radiation therapy. Giving celecoxib together with fluorouracil and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving celecoxib together with fluorouracil and radiation therapy works in treating patients with stage II or stage III rectal cancer that can be removed by surgery.
OBJECTIVES:
OUTLINE: This is a pilot study.
Patients receive oral celecoxib twice daily beginning 5 days prior to radiotherapy and continuing until completion of radiotherapy. Patients undergo radiotherapy 5 days a week for 5 weeks. Patients also receive concurrent fluorouracil IV continuously for 5 weeks. Patients undergo radical resection 4-10 weeks after completion of chemoradiotherapy.
Patients undergo tumor biopsy at baseline and then at the time of surgical resection. Patients also undergo blood and urine collection at baseline, 5 days after initiation of celecoxib, 7 days after initiation of celecoxib in combination with fluorouracil and radiotherapy, and at the time of surgical resection. The specimens are evaluated for COX-2 expression, eicosanoid production, and gene and protein expression using immunohistochemistry, microarray, and mass spectrometry.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 28 patients will be accrued for this study.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 24 is below the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Vanderbilt-Ingram Cancer Center is the lead sponsor of 220 studies on the registry; 32 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed primary adenocarcinoma of the rectum
Distal border of tumor must be at or below the peritoneal reflection
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Drug: celecoxib · Drug: fluorouracil · Procedure: conventional surgery · Radiation: radiation therapy · Procedure: tumor biopsy · Other: laboratory biomarker analysis
twice daily beginning 5 days prior to radiotherapy and continuing until completion of radiotherapy
Patients receive concurrent fluorouracil IV continuously for 5 weeks.
4-10 weeks after completion of chemoradiotherapy
Patients undergo radiotherapy 5 days a week for 5 weeks
at baseline and then at the time of surgical resection
blood and urine collected at baseline, 5 days after initiation of celecoxib, 7 days after initiation of celecoxib in combination with fluorouracil and radiotherapy, and at the time of surgical resection. specimens are evaluated for COX-2 expression, eicosanoid production, and gene and protein expression using immunohistochemistry, microarray, and mass spectrometry.
Pathologic complete response rate
Time frame: at time of surgery, day 5
Complete resection rate
Time frame: at time of surgery, day 5
Patterns of failure
Time frame: during study, beginning day 5 forward
Survival
Time frame: at time of death
Toxicity
Time frame: 5 days before surgery & 5 days after surgery
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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Vanderbilt-Ingram Cancer Center