Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059618
Status:
COMPLETED
Last Update Posted:
2012-08-02
First Post:
2003-04-29
Brief Title:
PS-341 Plus Carboplatin in Platinum and Taxane Resistant Recurrent Ovarian Cancer Primary Peritoneal Cancer and Fallopian Tube Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase I Study Evaluating the Safety and Tolerability of PS-341Bortezomiband Carboplatin in Patients With Platinum- and Taxane-Resistant Recurrent Ovarian Cancer Primary Peritoneal Cancer and Fallopian Tube Cancer
Status:
COMPLETED
Status Verified Date:
2012-08
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 goal of this clinical research study is to find the highest safe dose of PS-341 that can be given with carboplatin chemotherapy as a treatment for patients with ovarian abdominal or fallopian tube cancer Researchers also hope to find out if giving these drugs together will help shrink or slow the growth of tumors in patients who are considered resistant to platinum drugs The safety of these drugs will also be studied
Detailed Description:
Bortezomib is a drug that turns off certain genes and proteins inside the cancer cell that are responsible for cell growth Researchers believe that when certain genes and proteins are turned off the ability of the cancer cell to survive is decreased
Before treatment starts participants will have a complete checkup blood tests a urine test a heart test a chest x-ray and either a CT scan or MRI scan Women able to have children must have a negative blood pregnancy test within 14 days of beginning treatment Blood tests and a complete checkup will also be done before each course of therapy and a month after treatment ends Approximately 2-3 teaspoons of blood will be obtained for routine blood tests each time blood is drawn during this study
Participants in this study will receive Bortezomib and carboplatin through a catheter tube placed in a vein This is Day 1 of therapy Bortezomib is given first over 5 to 10 seconds followed by carboplatin over one hour Bortezomib is then given alone on Days 4 8 and 11 There is no treatment given on Days 12-28 One course of therapy is 28 days long and includes one dose of carboplatin and 4 doses of Bortezomib All treatment is given on an outpatient basis at M D Anderson
There are 4 different dose levels of Bortezomib being studied The dose of Bortezomib that participants receive will depend on when they are enrolled It will also depend on whether or not other participants had side effects from their treatment Up to 6 patients could be treated at each dose
Before each course of therapy participants will have a physical exam and blood tests A CT scan or MRI scan is repeated after Cycles 2 and 4 and at the end of treatment Participants who have a partial or complete response the tumor shrinks by more than 50 or disappears completely will have a repeat CT or MRI 4 weeks later to confirm the response
Participants may receive up to 8 courses of treatment If the disease gets worse or if intolerable side effects occur participants will be taken off study
This is an investigational study Bortezomib is approved for use by the FDA in patients with multiple myeloma Carboplatin is approved by the FDA though its use with Bortezomib is experimental A total of 24 patients will take part in this study All will be enrolled at M D Anderson
Before treatment starts participants will have a complete checkup blood tests a urine test a heart test a chest x-ray and either a CT scan or MRI scan Women able to have children must have a negative blood pregnancy test within 14 days of beginning treatment Blood tests and a complete checkup will also be done before each course of therapy and a month after treatment ends Approximately 2-3 teaspoons of blood will be obtained for routine blood tests each time blood is drawn during this study
Participants in this study will receive Bortezomib and carboplatin through a catheter tube placed in a vein This is Day 1 of therapy Bortezomib is given first over 5 to 10 seconds followed by carboplatin over one hour Bortezomib is then given alone on Days 4 8 and 11 There is no treatment given on Days 12-28 One course of therapy is 28 days long and includes one dose of carboplatin and 4 doses of Bortezomib All treatment is given on an outpatient basis at M D Anderson
There are 4 different dose levels of Bortezomib being studied The dose of Bortezomib that participants receive will depend on when they are enrolled It will also depend on whether or not other participants had side effects from their treatment Up to 6 patients could be treated at each dose
Before each course of therapy participants will have a physical exam and blood tests A CT scan or MRI scan is repeated after Cycles 2 and 4 and at the end of treatment Participants who have a partial or complete response the tumor shrinks by more than 50 or disappears completely will have a repeat CT or MRI 4 weeks later to confirm the response
Participants may receive up to 8 courses of treatment If the disease gets worse or if intolerable side effects occur participants will be taken off study
This is an investigational study Bortezomib is approved for use by the FDA in patients with multiple myeloma Carboplatin is approved by the FDA though its use with Bortezomib is experimental A total of 24 patients will take part in this study All will be enrolled at M D 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