Celebrex With Preoperative Chemoradiation - Rectal Cancer

NCT00188565 | Completed Phase 1

• 2 other identifiers: UHN REB 02-0130-COntario Cancer ResearchNetwork
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal carcinoma is the third most common cause of death from cancer. Approximately, 30% of colorectal carcinomas involve the rectum. Optimizing local control in the pelvis while reducing treatment toxicity remains one of the principal goals of therapy for patients with locally advanced rectal carcinoma. Treatment strategies that achieve this goal will have a significant impact on our society.C linical trials have shown that this type of cancer is less likely to come back if chemotherapy and radiotherapy are added to surgery. A combination of all three types of therapy is now standard. Celecoxib (Celebrex®) is a drug that lessens the action of an enzyme called cyclooxygenase-2 (COX-2) also known as a "COX-2 inhibitor". It is an anti-inflammatory capsule (drug that reduces irritation) that is commonly used to treat arthritis. It is not a chemotherapy drug. Laboratory experiments have shown that such COX-2 inhibitors may increase the anti-cancer effect of radiotherapy, without increasing radiation side effects. This has not yet been confirmed in humans.The main purpose of this study is to confirm that celecoxib does not increase the side effects when given with radiotherapy and chemotherapy for rectal cancer. We shall also be looking at how effective the combination of radiotherapy, chemotherapy and celecoxib is in shrinking rectal cancer.

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (2)

• - To assess the safety of celecoxib at a maximum dose of 400 mg orally twice daily in combination with preop RT and continuous infusional 5-FU. Incidence of dose-limiting toxicity (DLT) will be determined.

• - To determine the efficacy of celecoxib in combination with preop RT and continuous infusional 5-FU. Pathologic complete response rate (pCR) will be used as the endpoint.

Secondary Outcomes (6)

• Failure rate - locoregional and distant

• Survival rate - disease-free and overall

• Wound complication rate

• Late toxicity incidence (RTOG criteria))

• Sphincter preservation rate

Interventions

Celecoxib DRUG

Eligibility Criteria

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

You may qualify if:

• patients with resectable or potentially resectable adenocarcinoma of the rectum
• clinical stage T2 N1-2 or T3-4 N0-2 (patients who require diverting loop colostomy are eligible)
• age greater than 18 years, ECOG performance status \< 2 (appendix, section 13.1)
• biopsy proven adenocarcinoma, superior margin of the tumour within 15cm of the anal verge on rigid sigmoidoscopy

You may not qualify if:

• Distant metastasis, Prior pelvic irradiation, Inflammatory bowel disease, Medical conditions which preclude radical therapy
• History of malignancy within five years (except nonmelanoma skin cancer, CIN cervix)
• Pregnancy
• Hypersensitivity to celecoxib, NSAID, sulfonamides or 5-FU
• Significant comorbid illness
• History of peptic ulcer disease or NSAID-related gastrointestinal bleeding
• Use of aspirin, other NSAID or coxib in the two weeks prior to study entry
• Neutrophil count \<1.5x109/L, platelet count \<100x109/L, serum bilirubin \>1.25xULN (upper limit of normal), AST/ALT \>3xULN, serum creatinine \>1.25xULN

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Ontario Cancer Research Network: collaborator
• Princess Margaret Hospital, Canada: collaborator

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Celecoxib

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

Study Officials

• John Kim, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: March 1, 2004
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: August 13, 2010

Record last verified: 2010-08

Locations

CA (1)