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
Recruitment status was Active, not recruiting
Sponsor:
University Health Network, Toronto
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 May 16, 2013