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Pilot COX-2 Activity in Early Stage Rectal Cancer -Short Term Administration of Celecoxib (SPORE)

18 Years
Not Enrolling
Colorectal Cancer

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Trial Information

Pilot COX-2 Activity in Early Stage Rectal Cancer -Short Term Administration of Celecoxib (SPORE)


- Determine cyclooxygenase-2 (COX-2) over-expression in tumor specimens from patients
with early-stage rectal cancer.

- Determine whether administration of a COX-2 inhibitor, celecoxib, results in changes in
tumor (COX-2 overexpressing) levels of eicosanoids but not in levels in the surrounding
normal tissue that is expected not to express COX-2.

- Determine whether surrogate markers of eicosanoid metabolism (i.e., serum VEGF levels,
tumor prostaglandin E_2 [PGE_2], and the major urinary metabolite of PGE_2 [PGE-M]) in
biological specimens from these patients correlate with changes noted in tumor tissue.

- Determine if there is a greater change in protein and gene expression from pretreatment
biopsy levels in patient tumor specimens (COX-2 overexpressing) vs specimens of
surrounding normal tissue (expected not to be COX-2 overexpressing).

OUTLINE: Patients receive oral celecoxib twice daily on days 1-5. Patients then undergo
planned local excision or definitive radical resection on day 6.

Tumor tissue and normal tissue (at least 5 cm away from the tumor) samples are collected
pretreatment. Post-treatment tissue samples are collected along with the surgery. Serum and
urine samples are obtained at baseline and after administration of celecoxib. Tumor and
normal tissue specimens are analyzed by assays measuring markers of cyclooxygenase-2 (COX-2)
activity (i.e., COX-2 mRNA and protein, tumor prostaglandin E_2 [PGE_2], and VEGF). Tissue
samples are also assessed by cDNA microarray and imaging mass spectrometry to determine
overall changes in gene and protein expression from pretreatment levels. Surrogate markers
of COX-2 activity in serum (i.e., VEGF) and urine (i.e., urinary metabolite of PGE_2
[PGE-M]) are also assessed and compared with changes noted in tumor tissue. COX-2 protein
levels are determined by immunohistochemistry in patients with limited pretreatment tumor
tissue specimens.

Inclusion Criteria:

- Clinical diagnosis of primary adenocarcinoma of the rectum (to be histologically
confirmed upon study entry)

- Tumor must be at or below the peritoneal reflection

- The distal border of the tumor is within 12 cm of the anal verge on proctoscopic

- Clinically resectable 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 (other than rectal cancer) that would preclude study

- No psychiatric condition that would preclude informed consent

- No history of allergy to celecoxib or any other NSAIDs, including acetylsalicylic
acid (i.e., aspirin), ibuprofen, or indomethacin

- No history of allergy to sulfonamides

Exclusion criteria:

Not noted


- At least 7 days since prior and no concurrent NSAIDs or other cyclooxygenase-2

- No concurrent warfarin, except low-dose warfarin (i.e., 1 mg/day) administered for

Type of Study:


Study Design:

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

Outcome Measure:

Event rate of over-expression of cyclooxygenase-2

Outcome Time Frame:

Pre and post 7 days administration of study drug

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 0174



Start Date:

July 2002

Completion Date:

April 2008

Related Keywords:

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



Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Veterans Administration Nashville, Tennessee  37212