Status:
COMPLETED
Celebrex - Cervix: Celecoxib in the Treatment of Patients With Locally Advanced Carcinoma of the Cervix
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
NCIC Clinical Trials Group
Princess Margaret Hospital, Canada
Conditions:
Cervix Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a phase I/II study to evaluate the safety and toxicity of celecoxib in combination with standard concurrent cisplatin and radiotherapy in women with locally advanced cervix cancer. In addition...
Eligibility Criteria
Inclusion
- Biopsy-proven carcinoma of the cervix, with visible/palpable tumours; FIGO stage T1B-3B, NO/1, MO, to be treated with definitive radiotherapy and chemotherapy
- ECOG performance status of 0, 1, or 2
- Adequate hematologic function; Granulocyte count greater than 1.5 x 109/L, Platelet count greater than 100 x 109/L
- Adequate organ function; Serum creatinine £ 1.25 x ULN, or a calculated creatinine clearance ³ 50 mL/min, Serum bilirubin £ 1.25 x ULN and AST/ALT £ 3xULN
- No prior treatment for cervix cancer
- Informed consent
Exclusion
- Use of an NSAID in the 2 weeks prior to study enrollment
- Patients with an active malignancy at another site
- Patients with significant cardiac, renal, or pulmonary disease or any other medical conditions that may preclude radical therapy
- Patients who have significant history of ischaemic heart disease or stroke who would be deemed not suitable for cessation of their daily prophylactic aspirin
- Patients with history of peptic ulcer disease or previous NSAID related gastrointestinal bleeding
- Patients with hypersensitivity to NSAIDS or celecoxib, or sulfonamides
- Patients who unwilling or unable to give informed consent
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00152828
Start Date
February 1 2001
End Date
January 1 2011
Last Update
February 9 2016
Active Locations (1)
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1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9