Celecoxib in Treating Patients With Early-Stage Rectal Cancer

NCT00608595 | Terminated DMC

• 2 other identifiers: VICC GI 0174VU-VICC-GI-0174
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Event rate of over-expression of cyclooxygenase-2

  Pre and post 7 days administration of study drug

• Percent change of eicosanoid level

  Pre and post celecoxib treatment ratio of eicosanoid production

• Percent change of VEGF and prostaglandin-M levels

  Pre and post celecoxib treatment VEGF and PGE-M levels

• Change of gene and protein expression pattern from pre- to post-treatment levels

  Pre and post celecoxib treatment

Study Arms (1)

Therapeutic Intervention/Celecoxib

EXPERIMENTAL

Celecoxib

Drug: celecoxib; Genetic: gene expression analysis; Genetic: protein expression analysis; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Other: mass spectrometry; Procedure: biopsy; Procedure: neoadjuvant therapy; Procedure: therapeutic conventional surgery

Interventions

celecoxib DRUG

Will be administered orally 400 mg po BID starting 5 days prior to planned surgical resection.

Also known as: Celebrex

Therapeutic Intervention/Celecoxib

gene expression analysis GENETIC

not noted

Therapeutic Intervention/Celecoxib

protein expression analysis GENETIC

Not noted

Therapeutic Intervention/Celecoxib

immunohistochemistry staining method OTHER

not noted

Therapeutic Intervention/Celecoxib

laboratory biomarker analysis OTHER

not noted

Therapeutic Intervention/Celecoxib

mass spectrometry OTHER

Therapeutic Intervention/Celecoxib

biopsy PROCEDURE

At the time of preoperative evaluation by surgeon as well as one week after administration of Celecoxib.

Therapeutic Intervention/Celecoxib

neoadjuvant therapy PROCEDURE

not noted

Therapeutic Intervention/Celecoxib

therapeutic conventional surgery PROCEDURE

not noted

Therapeutic Intervention/Celecoxib

Eligibility Criteria

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

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

Sponsors & Collaborators

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

Study Sites (2)

Veterans Administration

Nashville, Tennessee, 37212, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms

Interventions

Celecoxib; Gene Expression Profiling; Immunohistochemistry; Mass Spectrometry; Biopsy; Neoadjuvant Therapy

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; Genetic Techniques; Investigative Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Immunologic Techniques; Chemistry Techniques, Analytical; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Combined Modality Therapy; Therapeutics

Study Officials

• A. Bapsi Chakravarthy, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: January 30, 2008
• First Posted: February 6, 2008
• Study Start: July 1, 2002
• Primary Completion: May 1, 2004
• Study Completion: April 1, 2008
• Last Updated: March 5, 2013

Record last verified: 2013-03

Locations

US (2)