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NCT Number: NCT00188565

Celebrex With Preoperative Chemoradiation - Rectal Cancer

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celecoxib

Drug

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Ontario Cancer Research Network
  • Princess Margaret Hospital, Canada

Registry information

Official study title

A Phase I/II Trial of Celecoxib With Preoperative Chemoradiation for Resectable Rectal Cancer With In Vivo Analysis of Celecoxib Effector Pathways

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Sep 16, 2005
Registry last updated
Aug 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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