Celebrex - Cervix

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2005 by University Health Network, Toronto. Recruitment status was Active, not recruiting

First Received on September 7, 2005. Last Updated on October 27, 2005 History of Changes

Sponsor:	University Health Network, Toronto
Collaborators:	NCIC Clinical Trials Group Princess Margaret Hospital, Canada
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00152828

Purpose

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.

Condition	Intervention	Phase
Cervix Neoplasms	Drug: Celecoxib	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

Safety - Tolerance of concurrent celecoxib with standard cisplatin/radiotherapy

Secondary Outcome Measures:

Objective changes in tumour oxygenation and IFP
Objective molecular marker response (COX-2, PGE2, VEGF, apoptosis)

Estimated Enrollment:	45
Study Start Date:	February 2001

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152828

Locations

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

Sponsors and Collaborators

University Health Network, Toronto

NCIC Clinical Trials Group

Princess Margaret Hospital, Canada

Investigators

Principal Investigator:

Anthony Fyles, MD

Princess Margaret Hospital, Canada

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00152828 History of Changes
Other Study ID Numbers:	UHN REB 00-0431-C, National Cancer Instit.Canada
Study First Received:	September 7, 2005
Last Updated:	October 27, 2005
Health Authority:	Canada: Ethics Review Committee

Additional relevant MeSH terms:

Neoplasms
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012