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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

- 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.

Principal Investigator

John Kim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

Canada: Ethics Review Committee

Study ID:

UHN REB 02-0130-C

NCT ID:

NCT00188565

Start Date:

March 2004

Completion Date:

March 2009

Related Keywords:

  • Colorectal Neoplasms
  • Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms

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