Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032825
Status:
COMPLETED
Last Update Posted:
2019-11-21
First Post:
2002-04-03
Brief Title:
Ketoconazole Plus Docetaxel to Treat Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Trial of High Dose Ketoconazole Plus Weekly Docetaxel in Metastatic Androgen Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2012-05-04
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:
This study will determine the maximum dose of docetaxel that can be given safely in combination with ketoconazole for treating advanced prostate cancer Docetaxel is approved for the treatment of several other types of cancers ketoconazole is an approved antifungal medication that is also commonly used in high doses to treat prostate cancer
Patients 18 years of age and older with advanced prostate cancer that does not respond to hormone therapy may be eligible for this study Candidates will be screened with blood tests to evaluate liver kidney and other organ function and with x-rays scans or other imaging tests to determine the extent of disease
Participants will take the following medications
Docetaxel daily infused through a vein over 30 minutes in 4-week cycles-3 consecutive weeks of drug followed by one week of rest
Dexamethasone 12 hours and 1 hour before and 12 hours after docetaxel infusions to help prevent fluid retention caused by the docetaxel
Ketoconazole 3 times a day
Hydrocortisone twice a day to replace a loss of natural steroids caused by the ketoconazole
Patients will be hospitalized 1 to 2 days each for the first and second doses of docetaxel to allow for frequent blood draws to measure blood levels of the drug Ketoconazole will be started about 2 weeks after the first dose of docetaxel and the second dose of docetaxel will be given 2 days after that In order to determine the maximum tolerated dose of docetaxel the first few patients in the study will be given a low dose of the drug and subsequent patients will get increasingly higher doses until unacceptable side effects occur Because prostate cancer cells may grow if exposed to testosterone patients may have to have their testosterone production suppressed either surgically removal of the testicles or medically with an injection of leuprolide or goserelin which are luteinizing hormone-release hormone agonists that reduce the amount of testosterone
Imaging studies such as x-rays bone scans or computed tomography CT scans will be done about every 3 months to examine how the tumor is responding to therapy After six treatment cycles patients will have monthly chest x-rays to check for fluid around the lining of the lungs which may occur as a result of docetaxel therapy
Treatment is expected to continue for at least 3 to 6 months although this time could be shortened or extended depending on the tumor response to therapy or side effects of the drugs Patients who do not experience bad side effects and whose tumor does not grow during the first 3 treatment cycles will continue treatment those who experience unacceptable side effects will be taken off the study
Patients 18 years of age and older with advanced prostate cancer that does not respond to hormone therapy may be eligible for this study Candidates will be screened with blood tests to evaluate liver kidney and other organ function and with x-rays scans or other imaging tests to determine the extent of disease
Participants will take the following medications
Docetaxel daily infused through a vein over 30 minutes in 4-week cycles-3 consecutive weeks of drug followed by one week of rest
Dexamethasone 12 hours and 1 hour before and 12 hours after docetaxel infusions to help prevent fluid retention caused by the docetaxel
Ketoconazole 3 times a day
Hydrocortisone twice a day to replace a loss of natural steroids caused by the ketoconazole
Patients will be hospitalized 1 to 2 days each for the first and second doses of docetaxel to allow for frequent blood draws to measure blood levels of the drug Ketoconazole will be started about 2 weeks after the first dose of docetaxel and the second dose of docetaxel will be given 2 days after that In order to determine the maximum tolerated dose of docetaxel the first few patients in the study will be given a low dose of the drug and subsequent patients will get increasingly higher doses until unacceptable side effects occur Because prostate cancer cells may grow if exposed to testosterone patients may have to have their testosterone production suppressed either surgically removal of the testicles or medically with an injection of leuprolide or goserelin which are luteinizing hormone-release hormone agonists that reduce the amount of testosterone
Imaging studies such as x-rays bone scans or computed tomography CT scans will be done about every 3 months to examine how the tumor is responding to therapy After six treatment cycles patients will have monthly chest x-rays to check for fluid around the lining of the lungs which may occur as a result of docetaxel therapy
Treatment is expected to continue for at least 3 to 6 months although this time could be shortened or extended depending on the tumor response to therapy or side effects of the drugs Patients who do not experience bad side effects and whose tumor does not grow during the first 3 treatment cycles will continue treatment those who experience unacceptable side effects will be taken off the study
Detailed Description:
High dose ketoconazole and weekly docetaxel have both been shown to have activity against androgen independent prostate cancer AIPC We have demonstrated synergy in prostate cancer in an in vitro model This is an open label phase I study of high-dose ketoconazole plus weekly docetaxel in patients with metastatic AIPC The primary objective of this study will be to determine the side effect profile of ketoconazole when combined with weekly docetaxel therapy and determine the maximum tolerated dose MTD and a recommended phase II dose RPIID of docetaxel when combined with high dose ketoconazole Since ketoconazole may alter the metabolism of docetaxel this study will evaluate potential drug interactions and adverse events between these two agents Ketoconazole dose will be 600mg per day given 200 mg three times a day plus 30mg of hydrocortisone 20mg in the morning and 10mg in the evening plus docetaxel 10-43 mgm2 in a dose escalation repeated in 28-day cycles comprising weekly treatments for three consecutive weeks followed by one week off Each patient will be evaluated every four weeks for the duration of the study
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 |
|---|---|---|---|
| 02-C-0149 | None | None | None |