Celebrex - Cervix

Condition(s) targeted: Cervix Neoplasms

Intervention: Celecoxib (Drug)

Phase: Phase 1/Phase 2

Status: Active, not recruiting

Sponsored by: University Health Network, Toronto

Official(s) and/or principal investigator(s):
Anthony Fyles, MD, Principal Investigator, Affiliation: Princess Margaret Hospital, Canada

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.

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Safety - Tolerance of concurrent celecoxib with standard cisplatin/radiotherapy

Secondary outcome:

Objective changes in tumour oxygenation and IFP

Objective molecular marker response (COX-2, PGE2, VEGF, apoptosis)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Princess Margaret Hospital, Toronto, Ontario M5G 2M9, Canada

Starting date: February 2001
Last updated: October 27, 2005