Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136487
Status:
COMPLETED
Last Update Posted:
2009-12-09
First Post:
2005-08-26
Brief Title:
Celecoxib Celebrex Versus Placebo in Men With Recurrent Prostate Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 An increase or decrease in this level in the blood can indicate if a patients 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 patients doctor will know whether heshe 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 patients doctor will discuss other available treatment options with himher 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 patients doctor will discuss available treatment options with himher 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
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 patients doctor will know whether heshe 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 patients doctor will discuss other available treatment options with himher 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 patients doctor will discuss available treatment options with himher 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| COXAON-0509-125 | None | None | None |