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

University Health Network, Toronto

Status and phase

Completed

Phase 2

Phase 1

Conditions

Cervix Neoplasms

Treatments

Drug: Celecoxib

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT00152828

National Cancer Instit.Canada

UHN REB 00-0431-C

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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