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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

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

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


- Determine cyclo-oxygenase-2 (COX-2) overexpression in patients with resectable stage II
or III rectal cancer treated with neoadjuvant celecoxib, fluorouracil, and

- 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

- 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

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.

Inclusion Criteria


- 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


- 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

- 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


- 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)

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologic complete response rate

Outcome Time Frame:

at time of surgery, day 5

Safety Issue:


Principal Investigator

A. Bapsi Chakravarthy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Federal Government

Study ID:

VICC GI 0173



Start Date:

July 2002

Completion Date:

March 2008

Related Keywords:

  • Colorectal Cancer
  • stage II rectal cancer
  • stage III rectal cancer
  • adenocarcinoma of the rectum
  • Rectal Neoplasms
  • Colorectal Neoplasms



Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus Nashville, Tennessee  37212