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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Celecoxib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Celecoxib may make tumor cells more sensitive to radiation therapy. Giving celecoxib together with fluorouracil and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving celecoxib together with fluorouracil and radiation therapy works in treating patients with stage II or stage III rectal cancer that can be removed by surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

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

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

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)