Celecoxib in Treating Patients With Early-Stage Rectal Cancer

• Status: Terminated
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Studying samples of tissue, blood, and urine from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how rectal cancer will respond to treatment with celecoxib.

PURPOSE: This clinical trial is studying how well celecoxib works in treating patients with early-stage rectal cancer.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Celecoxib

Criteria

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 examination

• Clinically resectable disease

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 (other than rectal cancer) that would preclude study therapy

• 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

PRIOR CONCURRENT THERAPY:

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

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