Celebrex With Preoperative Chemoradiation - Rectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00188565
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : August 13, 2010
Ontario Cancer Research Network
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: Celecoxib Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2004
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Primary Outcome Measures :
  1. - 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.
  2. - 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 :
  1. Failure rate - locoregional and distant
  2. Survival rate - disease-free and overall
  3. Wound complication rate
  4. Late toxicity incidence (RTOG criteria))
  5. Sphincter preservation rate
  6. Quality of life (FACT, EORTC)

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00188565

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
Principal Investigator: John Kim, MD Princess Margaret Hospital, Canada Identifier: NCT00188565     History of Changes
Other Study ID Numbers: UHN REB 02-0130-C
Ontario Cancer ResearchNetwork
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: August 13, 2010
Last Verified: August 2010

Additional relevant MeSH terms:
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
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents