search
Back to results

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

Primary Purpose

Cervix Neoplasms

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Celecoxib
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervix Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Princess Margaret Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Celecoxib

Arm Description

Celecoxib

Outcomes

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)

Full Information

First Posted
September 7, 2005
Last Updated
February 8, 2016
Sponsor
University Health Network, Toronto
Collaborators
NCIC Clinical Trials Group, Princess Margaret Hospital, Canada
search

1. Study Identification

Unique Protocol Identification Number
NCT00152828
Brief Title
Celebrex - Cervix: Celecoxib in the Treatment of Patients With Locally Advanced Carcinoma of the Cervix
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 Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
NCIC Clinical Trials Group, Princess Margaret Hospital, Canada

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervix Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Celecoxib
Arm Type
Experimental
Arm Description
Celecoxib
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Primary Outcome Measure Information:
Title
Safety - Tolerance of concurrent celecoxib with standard cisplatin/radiotherapy
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Objective changes in tumour oxygenation and IFP
Time Frame
1 year
Title
Objective molecular marker response (COX-2, PGE2, VEGF, apoptosis)
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Fyles, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs