Colorectal NeoplasmsPhase 1/2NCT00188565
Celebrex With Preoperative Chemoradiation - Rectal Cancer
A Phase 1/2 study testing Celecoxib in people with Colorectal Neoplasms, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Colorectal carcinoma is the third most common cause of death from cancer. Approximately, 30% of colorectal carcinomas involve the rectum. Optimizing local control in the pelvis while reducing treatment toxicity remains one of the principal goals of therapy for patients with locally advanced rectal carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Celecoxib
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2004to Mar 2009
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with resectable or potentially resectable adenocarcinoma of the rectum
- clinical stage T2 N1-2 or T3-4 N0-2 (patients who require diverting loop colostomy are eligible)
- age greater than 18 years, ECOG performance status < 2 (appendix, section 13.1)
- biopsy proven adenocarcinoma, superior margin of the tumour within 15cm of the anal verge on rigid sigmoidoscopy
Who cannot join
- Distant metastasis, Prior pelvic irradiation, Inflammatory bowel disease, Medical conditions which preclude radical therapy
- History of malignancy within five years (except nonmelanoma skin cancer, CIN cervix)
- Pregnancy
- Hypersensitivity to celecoxib, NSAID, sulfonamides or 5-FU
- Significant comorbid illness
- History of peptic ulcer disease or NSAID-related gastrointestinal bleeding
- Use of aspirin, other NSAID or coxib in the two weeks prior to study entry
- Neutrophil count <1.5x109/L, platelet count <100x109/L, serum bilirubin >1.25xULN (upper limit of normal), AST/ALT >3xULN, serum creatinine >1.25xULN
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Trial of Celecoxib With Preoperative Chemoradiation for Resectable Rectal Cancer With In Vivo Analysis of Celecoxib Effector Pathways
Colorectal carcinoma is the third most common cause of death from cancer. Approximately, 30% of colorectal carcinomas involve the rectum. Optimizing local control in the pelvis while reducing treatment toxicity remains one of the principal goals of therapy for patients with locally advanced rectal carcinoma. Treatment strategies that achieve this goal will have a significant impact on our society.C linical trials have shown that this type of cancer is less likely to come back if chemotherapy and radiotherapy are added to surgery. A combination of all three types of therapy is now standard.
Celecoxib (Celebrex®) is a drug that lessens the action of an enzyme called cyclooxygenase-2 (COX-2) also known as a "COX-2 inhibitor". It is an anti-inflammatory capsule (drug that reduces irritation) that is commonly used to treat arthritis. It is not a chemotherapy drug. Laboratory experiments have shown that such COX-2 inhibitors may increase the anti-cancer effect of radiotherapy, without increasing radiation side effects. This has not yet been confirmed in humans.The main purpose of this study is to confirm that celecoxib does not increase the side effects when given with radiotherapy and chemotherapy for rectal cancer. We shall also be looking at how effective the combination of radiotherapy, chemotherapy and celecoxib is in shrinking rectal cancer.
- Conditions
- Colorectal Neoplasms
- Being tested
- Celecoxib
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
- To assess the safety of celecoxib at a maximum dose of 400 mg orally twice daily in combination with preop RT and continuous infusional 5-FU. Incidence of dose-limiting toxicity (DLT) will be determined.
- To determine the efficacy of celecoxib in combination with preop RT and continuous infusional 5-FU. Pathologic complete response rate (pCR) will be used as the endpoint.
Secondary outcomes (6)
Failure rate - locoregional and distant
Survival rate - disease-free and overall
Wound complication rate
Late toxicity incidence (RTOG criteria))
Sphincter preservation rate
Quality of life (FACT, EORTC)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMar 2004
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Cancer Research Network, Princess Margaret Hospital, Canada
- Investigators
- John Kim, MD, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188565
- Sponsor's protocol ID
- UHN REB 02-0130-C
- Other IDs
- Ontario Cancer ResearchNetwork
- Status last verified
- Aug 2010
- First submitted
- 12 Sep 2005
- Last updated
- 13 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Celecoxib With Preoperative Chemoradiation for Resectable Rectal Cancer With In Vivo Analysis of Celecoxib Effector Pathways
- ClinicalTrials.gov ID
- NCT00188565
- Acronym / sponsor ID
- UHN REB 02-0130-C
- Conditions
- Colorectal Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Ontario Cancer Research Network, Princess Margaret Hospital, Canada
- Study start
- Mar 2004
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 16 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.
Colorectal carcinoma is the third most common cause of death from cancer. Approximately, 30% of colorectal carcinomas involve the rectum. Optimizing local control in the pelvis while reducing treatment toxicity remains one of the principal goals of therapy for patients with locally advanced rectal carcinoma. Treatment strategies that achieve this goal will have a significant impact on our society.C linical trials have shown that this type of cancer is less likely to come back if chemotherapy and radiotherapy are added to surgery. A combination of all three types of therapy is now standard.
Celecoxib (Celebrex®) is a drug that lessens the action of an enzyme called cyclooxygenase-2 (COX-2) also known as a "COX-2 inhibitor". It is an anti-inflammatory capsule (drug that reduces irritation) that is commonly used to treat arthritis. It is not a chemotherapy drug. Laboratory experiments have shown that such COX-2 inhibitors may increase the anti-cancer effect of radiotherapy, without increasing radiation side effects. This has not yet been confirmed in humans.The main purpose of this study is to confirm that celecoxib does not increase the side effects when given with radiotherapy and chemotherapy for rectal cancer. We shall also be looking at how effective the combination of radiotherapy, chemotherapy and celecoxib is in shrinking rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with resectable or potentially resectable adenocarcinoma of the rectum
- clinical stage T2 N1-2 or T3-4 N0-2 (patients who require diverting loop colostomy are eligible)
- age greater than 18 years, ECOG performance status < 2 (appendix, section 13.1)
- biopsy proven adenocarcinoma, superior margin of the tumour within 15cm of the anal verge on rigid sigmoidoscopy
Key exclusion criteria (8 listed)
- Distant metastasis, Prior pelvic irradiation, Inflammatory bowel disease, Medical conditions which preclude radical therapy
- History of malignancy within five years (except nonmelanoma skin cancer, CIN cervix)
- Pregnancy
- Hypersensitivity to celecoxib, NSAID, sulfonamides or 5-FU
- Significant comorbid illness
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 | – |
Primary outcome
- To assess the safety of celecoxib at a maximum dose of 400 mg orally twice daily in combination with preop RT and continuous infusional 5-FU. Incidence of dose-limiting toxicity (DLT) will be determined.
- To determine the efficacy of celecoxib in combination with preop RT and continuous infusional 5-FU. Pathologic complete response rate (pCR) will be used as the endpoint.
6 secondary outcomes
Failure rate - locoregional and distant
Survival rate - disease-free and overall
Wound complication rate
Late toxicity incidence (RTOG criteria))
Sphincter preservation rate
Quality of life (FACT, EORTC)
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 13 Aug 2010.
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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.
John Kim, 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 Colorectal 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 4 inclusion and 8 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 13 Aug 2010. 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?
- To assess the safety of celecoxib at a maximum dose of 400 mg orally twice daily in combination with preop RT and continuous infusional 5-FU. Incidence of dose-limiting toxicity (DLT) will be determined.. The study lists 2 primary outcomes in all. 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 13 Aug 2010.