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

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. Identifier: NCT00152828
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : February 9, 2016
NCIC Clinical Trials Group
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Cervix Neoplasms Drug: Celecoxib Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
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
Study Start Date : February 2001
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Arm Intervention/treatment
Experimental: Celecoxib
Drug: Celecoxib

Primary Outcome Measures :
  1. Safety - Tolerance of concurrent celecoxib with standard cisplatin/radiotherapy [ Time Frame: 1 year ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

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 identifier (NCT number): NCT00152828

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

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Responsible Party: University Health Network, Toronto Identifier: NCT00152828     History of Changes
Other Study ID Numbers: UHN REB 00-0431-C
National Cancer Instit.Canada
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action