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Completed

NCT Number: NCT00152828

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

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.

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Key information

Conditions

Cervix Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celecoxib

Drug

Primary outcomes

  1. Safety - Tolerance of concurrent celecoxib with standard cisplatin/radiotherapy

    Time frame: 1 year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • NCIC Clinical Trials Group
  • Princess Margaret Hospital, Canada

Registry information

Official study title

A Phase I/II Trial of the Cyclooxygenase-2 Inhibitor Celecoxib in the Treatment of Patients With Locally Advanced Carcinoma of the Cervix

Important dates

Study start
2001
Primary completion
2011
Study completion
2011
First posted
Sep 9, 2005
Registry last updated
Feb 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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