Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Celecoxib, Fluorouracil, and Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer That Can Be Removed By Surgery

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Biomarker/Laboratory analysis, Treatment	Closed	18 and over	NCI	VICC-GI-0173 VICC-020031, NCT00336960

Special Category: SPORE trial

Objectives

1. Determine cyclo-oxygenase-2 (COX-2) overexpression in patients with resectable stage II or III rectal cancer treated with neoadjuvant celecoxib, fluorouracil, and radiotherapy.
2. 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.
3. 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.
4. Determine whether patients who express the greatest degree of change in gene and protein expression are those most likely to respond to therapy.
5. Assess the toxicities of concurrent treatment with celecoxib, fluorouracil, and radiotherapy.

Entry Criteria

Disease Characteristics:

• Histologically confirmed primary adenocarcinoma of the rectum
  • Stage II or III disease



• Distal border of tumor must be at or below the peritoneal reflection
  • Distal border of the tumor must be within 12 cm of the anal verge by proctoscopic exam



• Tumor must be clinically resectable



• Transmural penetration beyond muscularis propria by transrectal ultrasound



• No high-grade obstruction



• No evidence of metastatic disease

Prior/Concurrent Therapy:

• No prior radiotherapy to the pelvis
• At least 7 days since prior and no other concurrent COX-2 inhibitors or nonsteroidal anti-inflammatory drugs (NSAIDs)
• No concurrent warfarin except low-dose warfarin (1 mg/day)

Patient Characteristics:

• Karnofsky performance status 60-100%
• WBC ≥ 4,000/mm³
• Platelet count ≥ 150,000/mm³
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other serious medical illness or psychiatric condition that would preclude study treatment
• No history of allergy to celecoxib or any other NSAIDs
• No history of allergy to sulfonamides
• No prior or concurrent malignancy except inactive noninvasive cervical carcinoma or skin cancer (excluding melanoma) or other cancer that has been disease free for ≥ 5 years

Expected Enrollment

Approximately 40 patients will be accrued for this study.

Outcomes

Pathologic complete response rate
Toxicity

Complete resection rate
Patterns of failure
Survival

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.

Trial Contact Information

Trial Lead Organizations

Vanderbilt-Ingram Cancer Center

A. Bapsi Chakravarthy, MD, Principal investigator		Ph: 615-322-2555; 800-811-8480 Email: bapsi.chak@vanderbilt.edu

Registry Information
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 II/III Resectable Rectal Cancer
Trial Start Date		2002-07-10
Registered in ClinicalTrials.gov		NCT00336960
Date Submitted to PDQ		2006-04-12
Information Last Verified		2006-06-12
NCI Grant/Contract Number		CA68485, CA95103

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