Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134706
Status:
COMPLETED
Last Update Posted:
2009-12-09
First Post:
2005-08-24
Brief Title:
A Study of Docetaxel Plus Carboplatin in Patients With Hormone Refractory Prostate Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Study of Docetaxel Plus Carboplatin in Hormone Refractory Prostate Cancer Patients Refractory to Prior Docetaxel-based Chemotherapy
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 look at the effects good and bad of the combination of docetaxel and carboplatin for patients who have progressive prostate cancer after chemotherapy with drugs such as docetaxel The investigators are also studying whether the measurement of two proteins in the blood may predict who will respond to the combination of docetaxel and carboplatin
Detailed Description:
Patients will receive both carboplatin and docetaxel This treatment is given in the outpatient department once every 3 weeks called one cycle
One day prior to the day of chemotherapy patients are given a steroid drug dexamethasone to be taken twice a day for 3 days This helps to decrease the risk of an allergic reaction
On the day of chemotherapy both docetaxel and carboplatin will be given through a vein over two to three hours Docetaxel will be given before carboplatin In addition patients receive zofran an anti-vomiting agent to try to prevent nausea and vomiting Study participants are also given a prescription for anti-nausea pills to take at home
After each cycle of treatment patients are required to get their bloods checked between days 8-12 of the cycle This may be done at an outside laboratory closer to the patients home
Treatment will be repeated every three weeks provided the blood tests and physical examination done prior to each treatment are acceptable If a patient is not able to receive the next scheduled dose of chemotherapy the doctor will delay the treatment for a week to a maximum of two weeks beyond which the patient will be taken off the trial If there is a delay of more than one week or the study participant has significant side effects their doctor will decrease the dose of the carboplatin and docetaxel During the treatment period doctors may also prescribe medications to treat low red blood cells or low white blood cells
Before each cycle every 3 weeks there will be routine blood tests drawn about 3 teaspoons to monitor bone marrow liver and kidney functions These samples will look at two proteins in the blood and may help us predict who will respond to docetaxel and carboplatin We will also obtain CT scans after every 3 cycles of treatment and at the end of the study A bone scan will also be done after every 3 cycles if there was evidence of bone involvement on the first bone scan A bone scan may also be ordered during the study in patients without prior evidence of bone involvement if the doctor suspects that the cancer has now spread to the bone
One day prior to the day of chemotherapy patients are given a steroid drug dexamethasone to be taken twice a day for 3 days This helps to decrease the risk of an allergic reaction
On the day of chemotherapy both docetaxel and carboplatin will be given through a vein over two to three hours Docetaxel will be given before carboplatin In addition patients receive zofran an anti-vomiting agent to try to prevent nausea and vomiting Study participants are also given a prescription for anti-nausea pills to take at home
After each cycle of treatment patients are required to get their bloods checked between days 8-12 of the cycle This may be done at an outside laboratory closer to the patients home
Treatment will be repeated every three weeks provided the blood tests and physical examination done prior to each treatment are acceptable If a patient is not able to receive the next scheduled dose of chemotherapy the doctor will delay the treatment for a week to a maximum of two weeks beyond which the patient will be taken off the trial If there is a delay of more than one week or the study participant has significant side effects their doctor will decrease the dose of the carboplatin and docetaxel During the treatment period doctors may also prescribe medications to treat low red blood cells or low white blood cells
Before each cycle every 3 weeks there will be routine blood tests drawn about 3 teaspoons to monitor bone marrow liver and kidney functions These samples will look at two proteins in the blood and may help us predict who will respond to docetaxel and carboplatin We will also obtain CT scans after every 3 cycles of treatment and at the end of the study A bone scan will also be done after every 3 cycles if there was evidence of bone involvement on the first bone scan A bone scan may also be ordered during the study in patients without prior evidence of bone involvement if the doctor suspects that the cancer has now spread to the bone
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