Celecoxib in Treating Patients With Early-Stage Rectal Cancer

Stopped early · Not applicable

Conditions studied: Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT00608595

Run by

Vanderbilt-Ingram Cancer Center

People needed

10

Starts

2002-07-01

Expected to finish

2008-04-01

Last updated by the study team

2013-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Veterans Administration — Nashville, Tennessee, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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