Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00181558
Status:
COMPLETED
Last Update Posted:
2010-05-10
First Post:
2005-09-09
Brief Title:
Atrasentan and Zometa for Men With Prostate Cancer Metastatic to Bone
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Atrasentan and Zometa for Men With Androgen Independent Prostate Cancer Metastatic to Bone A Randomized Pilot Study
Status:
COMPLETED
Status Verified Date:
2010-05
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 main purpose of this study is to look at the effects good or bad that Atrasentan given alone and Atrasentan given with Zometa has on levels of bone formation and bone destruction in men with prostate cancer that has spread to the bones
Detailed Description:
Patients will be randomized to either receive Atrasentan alone or Atrasentan plus Zometa
Patients receiving Atrasentan alone will receive this drug in pill form once daily for 12 weeks Patients will have a physical exam blood work and a urine sample performed once every other week during the first four weeks of medication administration After those two initial visits they will return to the clinic once every 4 weeks to have the same tests repeated A bone scan and abdominal-pelvic CT Scan will be done every 12 weeks
After the patient has been taking Atrasentan for 12 weeks if the disease has not progressed they will begin combination treatment of Atrasentan and Zometa
Patients receiving Atrasentan plus Zometa receive Zometa intravenously and then immediately start Atrasentan orally once daily as long as they remain on the study Patients will return to the clinic twice over the first 4 weeks once every other week to have a physical exam blood work and urine test performed After these two initial visits they will return to the clinic once every 4 weeks to have the tests repeated and to receive another treatment of zometa A bone scan and an abdominal-pelvic CT Scan will be done once every 12 weeks
Patients participation in this study will last as long as the disease does not progress and they are not experiencing any serious side effects
Patients receiving Atrasentan alone will receive this drug in pill form once daily for 12 weeks Patients will have a physical exam blood work and a urine sample performed once every other week during the first four weeks of medication administration After those two initial visits they will return to the clinic once every 4 weeks to have the same tests repeated A bone scan and abdominal-pelvic CT Scan will be done every 12 weeks
After the patient has been taking Atrasentan for 12 weeks if the disease has not progressed they will begin combination treatment of Atrasentan and Zometa
Patients receiving Atrasentan plus Zometa receive Zometa intravenously and then immediately start Atrasentan orally once daily as long as they remain on the study Patients will return to the clinic twice over the first 4 weeks once every other week to have a physical exam blood work and urine test performed After these two initial visits they will return to the clinic once every 4 weeks to have the tests repeated and to receive another treatment of zometa A bone scan and an abdominal-pelvic CT Scan will be done once every 12 weeks
Patients participation in this study will last as long as the disease does not progress and they are not experiencing any serious side effects
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