Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336960
Status:
COMPLETED
Last Update Posted:
2013-03-05
First Post:
2006-06-13
Brief Title:
Celecoxib Fluorouracil and Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer That Can Be Removed By Surgery
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Vanderbilt-Ingram Cancer Center
Study Overview
Official Title:
Phase II Pilot Study of Pre-Operative Celecoxib Celebrex in Combination With Prolonged Venous Infusion 5FU and Radiation Therapy for Patients With Stage IIIII Resectable Rectal Cancer
Status:
COMPLETED
Status Verified Date:
2013-03
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 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
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
Detailed Description:
OBJECTIVES
Determine cyclo-oxygenase-2 COX-2 overexpression in patients with resectable stage II or III rectal cancer treated with neoadjuvant celecoxib fluorouracil and radiotherapy
Determine whether administration of celecoxib a COX-2 inhibitor results in changes in tumor COX-2 overexpressing levels of eicosanoids but not in the surrounding normal tissue
Determine if there is a greater change in protein and gene expression in post-treatment biopsies when compared to pretreatment biopsies that are greater for tumor COX-2 overexpression than in surrounding normal tissue
Determine whether patients who express the greatest degree of change in gene and protein expression are those most likely to respond to therapy
Assess the toxicities of concurrent treatment with celecoxib fluorouracil and radiotherapy
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
Determine cyclo-oxygenase-2 COX-2 overexpression in patients with resectable stage II or III rectal cancer treated with neoadjuvant celecoxib fluorouracil and radiotherapy
Determine whether administration of celecoxib a COX-2 inhibitor results in changes in tumor COX-2 overexpressing levels of eicosanoids but not in the surrounding normal tissue
Determine if there is a greater change in protein and gene expression in post-treatment biopsies when compared to pretreatment biopsies that are greater for tumor COX-2 overexpression than in surrounding normal tissue
Determine whether patients who express the greatest degree of change in gene and protein expression are those most likely to respond to therapy
Assess the toxicities of concurrent treatment with celecoxib fluorouracil and radiotherapy
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
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 |
|---|---|---|---|
| VICC-020031 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA068485 |
| P50CA095103 | NIH | None | None |
| P30CA068485 | NIH | None | None |
| VICC-GI-0173 | None | None | None |