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

NCT00336960 | Completed Phase 2 DMC

• 5 other identifiers: VICC GI 0173P50CA095103P30CA068485VICC-GI-0173VICC-020031
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Colorectal Cancer

Keywords

stage II rectal cancer; stage III rectal cancer; adenocarcinoma of the rectum

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response rate

  at time of surgery, day 5

Secondary Outcomes (4)

• Complete resection rate

  at time of surgery, day 5

• Patterns of failure

  during study, beginning day 5 forward

• Survival

  at time of death

• Toxicity

  5 days before surgery & 5 days after surgery

Study Arms (1)

treatment intervention

EXPERIMENTAL

Drug: celecoxib; Drug: fluorouracil; Procedure: conventional surgery; Radiation: radiation therapy; Procedure: tumor biopsy; Other: laboratory biomarker analysis

Interventions

celecoxib DRUG

twice daily beginning 5 days prior to radiotherapy and continuing until completion of radiotherapy

treatment intervention

fluorouracil DRUG

Patients receive concurrent fluorouracil IV continuously for 5 weeks.

treatment intervention

conventional surgery PROCEDURE

4-10 weeks after completion of chemoradiotherapy

treatment intervention

radiation therapy RADIATION

Patients undergo radiotherapy 5 days a week for 5 weeks

treatment intervention

tumor biopsy PROCEDURE

at baseline and then at the time of surgical resection

treatment intervention

laboratory biomarker analysis OTHER

blood and urine collected 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. specimens are evaluated for COX-2 expression, eicosanoid production, and gene and protein expression using immunohistochemistry, microarray, and mass spectrometry.

treatment intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus

Nashville, Tennessee, 37212, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-5671, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms

Interventions

Celecoxib; Fluorouracil; Radiotherapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Pyrimidines; Therapeutics

Study Officials

• A. Bapsi Chakravarthy, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Medical Oncologist

Study Record Dates

• First Submitted: June 13, 2006
• First Posted: June 15, 2006
• Study Start: July 1, 2002
• Primary Completion: November 1, 2004
• Study Completion: March 1, 2008
• Last Updated: March 5, 2013

Record last verified: 2013-03

Locations

US (2)