Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059631
Status:
COMPLETED
Last Update Posted:
2018-11-15
First Post:
2003-04-29
Brief Title:
Phase I Study of Weekly Intravenous PS-341 Bortezomib Plus Mitoxantrone
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I Study of Weekly Intravenous PS-341 Bortezomib Plus Mitoxantrone in Patients With Advanced Androgen-Independent Prostate Cancer AI-PCa
Status:
COMPLETED
Status Verified Date:
2018-11
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:
Primary Objective
-Establish the dose-limiting toxicity DLT and maximum tolerated dose MTD of weekly mitoxantrone in combination with weekly PS-341 in patients with advanced AI-PCa
Secondary objectives
Evaluate the effect of bortezomib and mitoxantrone in combination on PSA levels among patients with baseline PSA levels 5 ngmL who are treated near the maximum tolerated dose
Monitor the effect of escalating doses of bortezomib combined with mitoxantrone on selected parameters of clinical benefit ie performance status tumor-related symptoms measurable disease response
-Establish the dose-limiting toxicity DLT and maximum tolerated dose MTD of weekly mitoxantrone in combination with weekly PS-341 in patients with advanced AI-PCa
Secondary objectives
Evaluate the effect of bortezomib and mitoxantrone in combination on PSA levels among patients with baseline PSA levels 5 ngmL who are treated near the maximum tolerated dose
Monitor the effect of escalating doses of bortezomib combined with mitoxantrone on selected parameters of clinical benefit ie performance status tumor-related symptoms measurable disease response
Detailed Description:
Mitoxantrone is used to treat bone pain in advanced prostate cancer and inhibits many proteins that the cancer cells need to multiply
Bortezomib is a member of a new class of drugs that possess powerful and broad-spectrum anti-tumor activity and inhibit many proteins that the cancer cells need to survive and multiply
Pre-study testing will include brief physical examination vital signs weight height temperature pulse respiratory and blood pressure chest x-ray EKG test to measure the electrical activity of the heart echocardiogram blood test urine tests and depending on the stage of the disease a CT scan andor bone scan
During treatment the participants will receive one dose of Mitoxantrone combined with one dose of Bortezomib every week for 4 weeks in a row followed by 2 weeks of rest this is called a course If side effects are not too severe Mitoxantrone and Bortezomib will be infused rapidly into a vein while participants will be receiving normal saline salt in water solution at a rate of 100mlhour They will receive the salt solution the entire time they are in the treatment area
Participants will have their vital signs temperature pulse breathing blood pressure taken before and one hour after treatment All side effects during course one will be reviewed and if no serious side effects took place the participant may have additional courses A pill may be given by mouth every day to decrease the risk of clot formation or a pill for diarrhea nausea andor vomiting if the doctor believes that participants may need it
Also during treatment participants will have a complete physical examination by a physician or their designated representative such as a nurse or physician assistant each week of treatment Bone Scan andor CT Scan will be done if necessary Participants will have blood tests done every week during study A special blood test called the 20S proteosome will be done weekly during Cycles 1 and 2 to evaluate the activity of the drugs Blood will be collected before you receive treatment and then at 1-2 hours afterward About 2 teaspoons of blood will be collected each time for this Bone scan chest x-ray andor CT scans will be repeated during the study every other course
Participants will be taken off study if the disease gets worse or intolerable side effects occur Side effects that are thought to be related to the study drug are renal failure resulting in death and a grade 3 rash requiring treatment with steroids that recurred with subsequent treatments
The maximum amount of time that participants can remain on the study is 8 courses of treatment Long term follow-up of participants will include a phone call every 6 months
This is an investigational study Bortezomib has been approved by the FDA for investigational use only Mitoxantrone has been approved by the FDA for treatment of symptoms in advanced prostate cancer Only Mitoxantrone is commercially available About 42 participants will take part in this study All will be enrolled at MD Anderson
Bortezomib is a member of a new class of drugs that possess powerful and broad-spectrum anti-tumor activity and inhibit many proteins that the cancer cells need to survive and multiply
Pre-study testing will include brief physical examination vital signs weight height temperature pulse respiratory and blood pressure chest x-ray EKG test to measure the electrical activity of the heart echocardiogram blood test urine tests and depending on the stage of the disease a CT scan andor bone scan
During treatment the participants will receive one dose of Mitoxantrone combined with one dose of Bortezomib every week for 4 weeks in a row followed by 2 weeks of rest this is called a course If side effects are not too severe Mitoxantrone and Bortezomib will be infused rapidly into a vein while participants will be receiving normal saline salt in water solution at a rate of 100mlhour They will receive the salt solution the entire time they are in the treatment area
Participants will have their vital signs temperature pulse breathing blood pressure taken before and one hour after treatment All side effects during course one will be reviewed and if no serious side effects took place the participant may have additional courses A pill may be given by mouth every day to decrease the risk of clot formation or a pill for diarrhea nausea andor vomiting if the doctor believes that participants may need it
Also during treatment participants will have a complete physical examination by a physician or their designated representative such as a nurse or physician assistant each week of treatment Bone Scan andor CT Scan will be done if necessary Participants will have blood tests done every week during study A special blood test called the 20S proteosome will be done weekly during Cycles 1 and 2 to evaluate the activity of the drugs Blood will be collected before you receive treatment and then at 1-2 hours afterward About 2 teaspoons of blood will be collected each time for this Bone scan chest x-ray andor CT scans will be repeated during the study every other course
Participants will be taken off study if the disease gets worse or intolerable side effects occur Side effects that are thought to be related to the study drug are renal failure resulting in death and a grade 3 rash requiring treatment with steroids that recurred with subsequent treatments
The maximum amount of time that participants can remain on the study is 8 courses of treatment Long term follow-up of participants will include a phone call every 6 months
This is an investigational study Bortezomib has been approved by the FDA for investigational use only Mitoxantrone has been approved by the FDA for treatment of symptoms in advanced prostate cancer Only Mitoxantrone is commercially available About 42 participants will take part in this study All will be enrolled at MD Anderson
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 |
|---|---|---|---|
| CDR0000355822 | REGISTRY | PDQ Identifier for ClinicalTrialsgov | httpsreporternihgovquickSearchP30CA016672 |
| P50CA090270 | NIH | None | None |
| P30CA016672 | NIH | None | None |
| MDA-ID-02227 | REGISTRY | None | None |