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