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
Sponsor:
Collaborators:
NCIC Clinical Trials Group
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00152828
First received: September 7, 2005
Last updated: October 27, 2005
Last verified: September 2005
  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: 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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014