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

A Phase I/II Trial of the Cyclooxygenase-2 Inhibitor Celecoxib in the Treatment of Patients With Locally Advanced Carcinoma of the Cervix

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.

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