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

This study has been completed.
NCIC Clinical Trials Group
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
First received: September 7, 2005
Last updated: February 8, 2016
Last verified: February 2016
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 1
Phase 2

Study Type: Interventional
Study Design: 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:

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

Primary Outcome Measures:
  • Safety - Tolerance of concurrent celecoxib with standard cisplatin/radiotherapy [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective changes in tumour oxygenation and IFP [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Objective molecular marker response (COX-2, PGE2, VEGF, apoptosis) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: February 2001
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Celecoxib
Drug: Celecoxib


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

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

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
Principal Investigator: Anthony Fyles, MD Princess Margaret Hospital, Canada
  More Information

Responsible Party: University Health Network, Toronto
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: February 8, 2016
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Cyclooxygenase 2 Inhibitors
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on May 23, 2016