Celebrex With Preoperative Chemoradiation - Rectal Cancer - Full Text View

Sponsor:	University Health Network, Toronto
Collaborators:	Ontario Cancer Research Network Princess Margaret Hospital, Canada
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00188565

Purpose

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.

Condition	Intervention	Phase
Colorectal Neoplasms	Drug: Celecoxib	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I/II Trial of Celecoxib With Preoperative Chemoradiation for Resectable Rectal Cancer With In Vivo Analysis of Celecoxib Effector Pathways

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

- 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 Outcome Measures:

Failure rate - locoregional and distant
Survival rate - disease-free and overall
Wound complication rate
Late toxicity incidence (RTOG criteria))
Sphincter preservation rate
Quality of life (FACT, EORTC)

Estimated Enrollment:	39
Study Start Date:	March 2004
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188565

Locations

Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9

Sponsors and Collaborators

University Health Network, Toronto

Ontario Cancer Research Network

Princess Margaret Hospital, Canada

Investigators

Principal Investigator:

John Kim, MD

Princess Margaret Hospital, Canada

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00188565 History of Changes
Other Study ID Numbers:	UHN REB 02-0130-C, Ontario Cancer ResearchNetwork
Study First Received:	September 12, 2005
Last Updated:	August 12, 2010
Health Authority:	Canada: Ethics Review Committee

Additional relevant MeSH terms:

Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors

Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012