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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00152828
First Posted: September 9, 2005
Last Update Posted: February 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
NCIC Clinical Trials Group
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
  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 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Objective changes in tumour oxygenation and IFP [ Time Frame: 1 year ]
  • Objective molecular marker response (COX-2, PGE2, VEGF, apoptosis) [ Time Frame: 1 year ]

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
Celecoxib
Drug: Celecoxib

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 7, 2005
First Posted: September 9, 2005
Last Update Posted: February 9, 2016
Last Verified: February 2016

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