Celebrex - Cervix: Celecoxib in the Treatment of Patients With Locally Advanced Carcinoma of the Cervix

Phase 1

Completed

• Conditions: Cervix Neoplasms
• Interventions: Drug: Celecoxib

• Registration Number: NCT00152828
• Lead Sponsor: University Health Network, Toronto

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, we aim to determine the effect of celecoxib (Celebrex) on tumour oxygenation, interstitial fluid pressure, COX-2 levels, prostaglandin E2 levels, angiogenesis and apoptosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-02
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-09
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-08
• Last Update Posted: 2016-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Celecoxib	Celecoxib	Celecoxib

Primary Outcome Measures

Name	Time	Method
Safety - Tolerance of concurrent celecoxib with standard cisplatin/radiotherapy	1 year

Secondary Outcome Measures

Name	Time	Method
Objective changes in tumour oxygenation and IFP	1 year
Objective molecular marker response (COX-2, PGE2, VEGF, apoptosis)	1 year

Trial Locations

Locations (1)

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada