Cervix NeoplasmsPhase 1/2NCT00152828
Celebrex - Cervix: Celecoxib in the Treatment of Patients With Locally Advanced Carcinoma of the Cervix
A Phase 1/2 study testing Celecoxib in people with Cervix Neoplasms, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervix Neoplasms
- What is being tested?
- Celecoxib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2001to Jan 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Cervix Neoplasms
- Being tested
- Celecoxib
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
| Study group | Role | What they receive |
|---|---|---|
| Celecoxib | Experimental | Celecoxib Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Tolerance of concurrent celecoxib with standard cisplatin/radiotherapy
Measured: 1 year
Secondary outcomes (2)
Objective changes in tumour oxygenation and IFP
Measured: 1 year
Objective molecular marker response (COX-2, PGE2, VEGF, apoptosis)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startFeb 2001
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervix NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- NCIC Clinical Trials Group, Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Anthony Fyles, MD, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152828
- Sponsor's protocol ID
- UHN REB 00-0431-C
- Other IDs
- National Cancer Instit.Canada
- Status last verified
- Feb 2016
- First submitted
- 7 Sep 2005
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00152828
- Acronym / sponsor ID
- UHN REB 00-0431-C
- Conditions
- Cervix Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- NCIC Clinical Trials Group, Princess Margaret Hospital, Canada
- Study start
- Feb 2001
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 9 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Celecoxib | Experimental | Drug: CelecoxibCelecoxib |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celecoxib | Drug | Celecoxib |
Primary outcome
Safety - Tolerance of concurrent celecoxib with standard cisplatin/radiotherapy
Time frame: 1 year
2 secondary outcomes
Objective changes in tumour oxygenation and IFP
Time frame: 1 year
Objective molecular marker response (COX-2, PGE2, VEGF, apoptosis)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
Related trials for Cervix Neoplasms
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Cervical Cancer
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Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer
Locally Advanced Cervical Adenocarcinoma, Locally Advanced Cervical Adenosquamous Carcinoma
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Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
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Enrolling by invitationObservational study
Use of cfDNA in Monitoring and Guiding Treatment for Cervical Cancer
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Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Fyles, MD principal investigator
Princess Margaret Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Celecoxib in people with Cervix Neoplasms, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Tolerance of concurrent celecoxib with standard cisplatin/radiotherapy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2016.