Prostate CancerPhase 2/3NCT00136487
Celecoxib (Celebrex) Versus Placebo in Men With Recurrent Prostate Cancer
A Phase 2/3 study testing Celecoxib in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 9 sites in United States.
Trial summary
The purpose of this study is to learn the effects (both good and bad) that celecoxib has on prostate cancer and patients with prostate cancer. This study is looking at what effects celecoxib has on prostate specific antigen (PSA) level. PSA is a marker specific to prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Celecoxib
- How many people
- 85 participants
- Where
- 9 sitesUnited States
- Study dates
- Oct 2002to Sep 2006
- Phase
- Phase 2/3
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of prostate cancer
- Progression following prostatectomy or radiation to the prostate, defined as 3 PSA rises, with each PSA determination at least 4 weeks apart
- PSA greater than or equal to 1.0 for men who had a prostatectomy
- PSA greater than or equal to 3.0 for men who were treated with primary radiation therapy (external beam and/or brachytherapy)
- PSA doubling time between 6 and 24 months
- Participants must be either fully active and asymptomatic or symptomatic but fully ambulatory
- Adequate bone marrow function, kidney function and liver function as evidenced by laboratory results
Who cannot join
- Evidence of metastatic disease
- Prior hormonal therapy for recurrent prostate cancer
- Prior chemotherapy for recurrent or metastatic prostate cancer
- Radiation therapy within 6 months
- Patients allergic to non-steroidal anti-inflammatory drugs (NSAIDs), salicylates or sulfonamide-type medications who experience asthma or urticaria (hives) after taking aspirin or other NSAIDs
- Patients taking a dose of aspirin greater than or equal to 325 mg a day within 4 weeks of study entry
Show all 11Show fewer
- Patients taking selective COX-2 inhibitors or any NSAIDs other than aspirin within 8 weeks of study entry
- Patients taking fluconazole, lithium or warfarin
- History of gastrointestinal or abdominal ulceration or any history of significant gastrointestinal bleeding in the past 12 months
- Any history of myocardial infarction in the past 12 months
- Any uncontrolled, serious medical or psychiatric illness
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Faulkner Hospital
Boston, Massachusetts, 02130
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Emerson Hospital
Concord, Massachusetts, 01742
Hartford Hospital
Hartford, Connecticut, 06102
MD Anderson Cancer Center
Houston, Texas, 77030
Lowell General Hospital
Lowell, Massachusetts, 01854
About this study
Official title: A Randomized, Double Blind, Placebo-Controlled Trial of Celecoxib Versus Placebo in Men With Prostate Cancer With Rising PSA Following Prostatectomy or Radiation Therapy
The purpose of this study is to learn the effects (both good and bad) that celecoxib has on prostate cancer and patients with prostate cancer. This study is looking at what effects celecoxib has on prostate specific antigen (PSA) level. PSA is a marker specific to prostate cancer. An increase or decrease in this level in the blood can indicate if a patient's prostate cancer is getting worse or better.
Read the detailed description
This study is designed as a randomized, double blind, placebo-controlled study. These are all scientific research methods used to protect the study from personal bias or prejudice.
Patients who participate in this study will be randomly assigned initially to take either celecoxib (the study drug) or placebo (an inactive substance that looks like the study drug). Placebos are used to help determine if the results of a study (good or bad) result from chance or from treatment with the study drug. Patients will have a fifty-fifty chance of initial treatment with the study drug. Neither the patient nor the patient's doctor will know whether he/she is initially receiving the study drug or placebo. Participants who are assigned to initially take placebo may have the opportunity to be treated with celecoxib later in the study.
If patients are found to be eligible for this study and they agree to participate, they will be randomized to either receive celecoxib or placebo to be taken by mouth (as a pill) twice a day, every day for as long as they are in the study. Patients will be given a pill diary to keep track of their medications. While in this study, they will be asked not to take any non-steroidal anti-inflammatory drugs, which includes over-the-counter ibuprofen and many other available drugs. In addition, they will be asked not to take any other selective COX-2 inhibitors (the class of drug that celecoxib is).
While in this study, patients will have evaluations (physical exam and blood) to determine their response to their assigned regimen and to monitor side effects.
Once a month the following will be performed:
- Review of any side effects
- Physical Exam
- Routine blood tests (PSA level, kidney function). About one tablespoon of blood will be taken at each visit.
Every other month starting with month 2:
In addition to the above evaluations, on alternating months starting with month 2, additional routine blood tests (liver function, complete blood count) will be done. This will require an additional tablespoon of blood to be taken at these visits.
Additional blood for research-related testing (about 2-3 tablespoons) will also be drawn during these visits.
Participation in this study will be determined by how well patients tolerate the assigned regimen and by how their disease responds. Patients will continue taking their assigned regimen for 6 months as long as it is felt that their disease is stable (based on their PSA levels) and they are tolerating the treatment. After 6 months or earlier, if the disease progresses, the treatment code will be broken. If patients were on celecoxib, they will be taken off study. The patient's doctor will discuss other available treatment options with him/her at that time, including continuing celecoxib "off study". If patients were on placebo, they will then have the option to begin taking celecoxib. If patients start celecoxib treatment, they will be treated in this study with celecoxib for 6 months or until their disease progresses. After 6 months on celecoxib or sooner, if their disease progresses, they will be taken off study. The patient's doctor will discuss available treatment options with him/her at that time, including continuing celecoxib "off study".
Patients who are taken "off study" will be monitored monthly for patient safety reasons throughout the duration of time that they are receiving celecoxib at the dose level used for this study (400mg twice a day).
- Conditions
- Prostate Cancer
- Being tested
- Celecoxib
- Keywords
- Prostate Cancer, Cancer of Prostate, Cancer of the Prostate, Prostate-Specific Antigen
- Medical subject headings
- Prostatic 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 evaluate the biologic activity of celecoxib by comparing the proportion of men with a post-treatment PSA doubling time (PSADT) greater than or equal to 200% pre-treatment PSADT in the celecoxib-treated group compared to the placebo-treated group
Secondary outcomes (3)
To compare changes in PSADT between the first and second six-month treatment periods for those in the placebo-treated group
to correlate COX-2 expression in the patients' original prostate samples with biologic activity of celecoxib (when feasible)
to correlate changes in plasma vascular endothelial growth factor (VEGF) levels in patients with biologic activity of celecoxib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startOct 2002
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 85 participants
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Beth Israel Deaconess Medical Center, Emerson Hospital, Concord, MA, Brigham and Women's Hospital, Hartford Hospital, Lowell General Hospital, Massachusetts General Hospital, M.D. Anderson Cancer Center, University of Michigan Rogel Cancer Center
- Investigators
- Philip W. Kantoff, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136487
- Sponsor's protocol ID
- 02-193
- Other IDs
- COXAON-0509-125
- Status last verified
- Dec 2009
- First submitted
- 26 Aug 2005
- Last updated
- 9 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-Controlled Trial of Celecoxib Versus Placebo in Men With Prostate Cancer With Rising PSA Following Prostatectomy or Radiation Therapy
- ClinicalTrials.gov ID
- NCT00136487
- Acronym / sponsor ID
- 02-193
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Cancer of Prostate, Cancer of the Prostate, Prostate-Specific Antigen
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Pfizer, Beth Israel Deaconess Medical Center, Emerson Hospital, Concord, MA, Brigham and Women's Hospital, Hartford Hospital, Lowell General Hospital, Massachusetts General Hospital, M.D. Anderson Cancer Center, University of Michigan Rogel Cancer Center
- Study start
- Oct 2002
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 29 Aug 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.
The purpose of this study is to learn the effects (both good and bad) that celecoxib has on prostate cancer and patients with prostate cancer. This study is looking at what effects celecoxib has on prostate specific antigen (PSA) level. PSA is a marker specific to prostate cancer. An increase or decrease in this level in the blood can indicate if a patient's prostate cancer is getting worse or better.
Detailed description
This study is designed as a randomized, double blind, placebo-controlled study. These are all scientific research methods used to protect the study from personal bias or prejudice.
Patients who participate in this study will be randomly assigned initially to take either celecoxib (the study drug) or placebo (an inactive substance that looks like the study drug). Placebos are used to help determine if the results of a study (good or bad) result from chance or from treatment with the study drug. Patients will have a fifty-fifty chance of initial treatment with the study drug. Neither the patient nor the patient's doctor will know whether he/she is initially receiving the study drug or placebo. Participants who are assigned to initially take placebo may have the opportunity to be treated with celecoxib later in the study.
If patients are found to be eligible for this study and they agree to participate, they will be randomized to either receive celecoxib or placebo to be taken by mouth (as a pill) twice a day, every day for as long as they are in the study. Patients will be given a pill diary to keep track of their medications. While in this study, they will be asked not to take any non-steroidal anti-inflammatory drugs, which includes over-the-counter ibuprofen and many other available drugs. In addition, they will be asked not to take any other selective COX-2 inhibitors (the class of drug that celecoxib is).
While in this study, patients will have evaluations (physical exam and blood) to determine their response to their assigned regimen and to monitor side effects.
Once a month the following will be performed:
- Review of any side effects
- Physical Exam
- Routine blood tests (PSA level, kidney function). About one tablespoon of blood will be taken at each visit.
Every other month starting with month 2:
In addition to the above evaluations, on alternating months starting with month 2, additional routine blood tests (liver function, complete blood count) will be done. This will require an additional tablespoon of blood to be taken at these visits.
Additional blood for research-related testing (about 2-3 tablespoons) will also be drawn during these visits.
Participation in this study will be determined by how well patients tolerate the assigned regimen and by how their disease responds. Patients will continue taking their assigned regimen for 6 months as long as it is felt that their disease is stable (based on their PSA levels) and they are tolerating the treatment. After 6 months or earlier, if the disease progresses, the treatment code will be broken. If patients were on celecoxib, they will be taken off study. The patient's doctor will discuss other available treatment options with him/her at that time, including continuing celecoxib "off study". If patients were on placebo, they will then have the option to begin taking celecoxib. If patients start celecoxib treatment, they will be treated in this study with celecoxib for 6 months or until their disease progresses. After 6 months on celecoxib or sooner, if their disease progresses, they will be taken off study. The patient's doctor will discuss available treatment options with him/her at that time, including continuing celecoxib "off study".
Patients who are taken "off study" will be monitored monthly for patient safety reasons throughout the duration of time that they are receiving celecoxib at the dose level used for this study (400mg twice a day).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of prostate cancer
- Progression following prostatectomy or radiation to the prostate, defined as 3 PSA rises, with each PSA determination at least 4 weeks apart
- PSA greater than or equal to 1.0 for men who had a prostatectomy
- PSA greater than or equal to 3.0 for men who were treated with primary radiation therapy (external beam and/or brachytherapy)
- PSA doubling time between 6 and 24 months
Key exclusion criteria (11 listed)
- Evidence of metastatic disease
- Prior hormonal therapy for recurrent prostate cancer
- Prior chemotherapy for recurrent or metastatic prostate cancer
- Radiation therapy within 6 months
- Patients allergic to non-steroidal anti-inflammatory drugs (NSAIDs), salicylates or sulfonamide-type medications who experience asthma or urticaria (hives) after taking aspirin or other NSAIDs
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 evaluate the biologic activity of celecoxib by comparing the proportion of men with a post-treatment PSA doubling time (PSADT) greater than or equal to 200% pre-treatment PSADT in the celecoxib-treated group compared to the placebo-treated group
3 secondary outcomes
To compare changes in PSADT between the first and second six-month treatment periods for those in the placebo-treated group
to correlate COX-2 expression in the patients' original prostate samples with biologic activity of celecoxib (when feasible)
to correlate changes in plasma vascular endothelial growth factor (VEGF) levels in patients with biologic activity of celecoxib
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 Dec 2009.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Philip W. Kantoff, MD principal investigator
Dana-Farber Cancer Institute
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Celecoxib in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 9 sites in United States.
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 7 inclusion and 11 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 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 evaluate the biologic activity of celecoxib by comparing the proportion of men with a post-treatment PSA doubling time (PSADT) greater than or equal to 200% pre-treatment PSADT in the celecoxib-treated group compared to the placebo-treated group. 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 Dec 2009.