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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00152828

Enrollment

Registered

2005-09-09

Start date

2001-02-28

Completion date

2011-01-31

Last updated

2016-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervix Neoplasms

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.

Interventions

DRUGCelecoxib

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Safety - Tolerance of concurrent celecoxib with standard cisplatin/radiotherapy	1 year

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026