Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00317772
Status:
COMPLETED
Last Update Posted:
2022-02-07
First Post:
2006-04-21
Brief Title:
Topotecan and Gefitinib Iressa for Ovarian Peritoneal or Fallopian Tube Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase III Study of Weekly Topotecan and Gefitinib Iressa in Patients With Platinum-Resistant Ovarian Peritoneal of Fallopian Tube Cancer
Status:
COMPLETED
Status Verified Date:
2022-01
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 purposes of this study are
1 To determine the dose limiting toxicity DLT and the maximum tolerated dose MTD weekly of topotecan in combination with standard dose gefitinib in patients with relapsed platinum-resistant ovarian peritoneal or fallopian tube cancers that are epidermal growth factor receptor EGF-R positive 1
2 To determine the response rate and response duration in this patient population treated with the maximum tolerated dose MTD of topotecan administered on a weekly schedule in combination with standard dose gefitinib given by way of the mouth PO daily
1 To determine the dose limiting toxicity DLT and the maximum tolerated dose MTD weekly of topotecan in combination with standard dose gefitinib in patients with relapsed platinum-resistant ovarian peritoneal or fallopian tube cancers that are epidermal growth factor receptor EGF-R positive 1
2 To determine the response rate and response duration in this patient population treated with the maximum tolerated dose MTD of topotecan administered on a weekly schedule in combination with standard dose gefitinib given by way of the mouth PO daily
Detailed Description:
Gefitinib inhibits the activity of a molecule present on the cancer cell that plays a role in cancer cell growth Topotecan is an FDA approved drug used to treat ovarian cancer that is still present after treatment with chemotherapy It is also used to treat recurrent ovarian cancer patients whose cancer returns after they have been cancer-free for a period of time
Before treatment starts you will have a complete physical exam routine blood tests about 2-3 teaspoons a chest x-ray and a CT scan or MRI Women who are able to have children must have a negative blood pregnancy test
There are 2 phases to this study In the first phase 3 different dose levels of topotecan are being studied The dose of topotecan that you receive will depend on when you are enrolled It will also depend on whether or not other participants had side effects from their treatment Although the dose of topotecan will vary the dose of gefitinib is the same for all participants Up to 6 participants may be treated at each dose The goal of this portion of the study is to find the highest safe dose of this drug combination Up to 18 patients will be treated on this part of the study
Once the highest safe dose of topotecan has been found the second phase of the study will begin In this phase all participants will receive the same dose of topotecan and gefitinib Up to 40 patients will be enrolled in this part of the study but 6 will be from the 1st portion of the study
Each treatment cycle is 28 days long You will take one gefitinib tablet by mouth every day beginning on Day 1 In addition you will be given topotecan through a catheter tube placed in a vein over 30 minutes on Days 1 8 and 15
Blood tests to check your kidney liver and bone marrow function and a complete checkup physical examination including a pelvic and rectal exam will be done before each course of therapy and a month after treatment ends About 2-3 teaspoons of blood will be collected for routine blood tests each time blood is drawn during this study Follow up CT scans or MRI scans will be done after every 2 to 3 cycles to evaluate your response to treatment
You will be taken off study if your disease gets worse or intolerable side effects occur If you have a complete response to this therapy no evidence of cancer then treatment will continue for an additional 6 months and then stop All treatment is given on an outpatient basis at UTMDACC
You will be monitored for at least 30 days after your last dose of therapy If you have side effects related to this treatment combination you will be monitored longer until the side effects have gone away
This is an investigational study Both gefitinib and topotecan are FDA approved and commercially available However their use together in this study is investigational A total of up to 52 patients will take part in this study All will be enrolled at UTMDACC
Before treatment starts you will have a complete physical exam routine blood tests about 2-3 teaspoons a chest x-ray and a CT scan or MRI Women who are able to have children must have a negative blood pregnancy test
There are 2 phases to this study In the first phase 3 different dose levels of topotecan are being studied The dose of topotecan that you receive will depend on when you are enrolled It will also depend on whether or not other participants had side effects from their treatment Although the dose of topotecan will vary the dose of gefitinib is the same for all participants Up to 6 participants may be treated at each dose The goal of this portion of the study is to find the highest safe dose of this drug combination Up to 18 patients will be treated on this part of the study
Once the highest safe dose of topotecan has been found the second phase of the study will begin In this phase all participants will receive the same dose of topotecan and gefitinib Up to 40 patients will be enrolled in this part of the study but 6 will be from the 1st portion of the study
Each treatment cycle is 28 days long You will take one gefitinib tablet by mouth every day beginning on Day 1 In addition you will be given topotecan through a catheter tube placed in a vein over 30 minutes on Days 1 8 and 15
Blood tests to check your kidney liver and bone marrow function and a complete checkup physical examination including a pelvic and rectal exam will be done before each course of therapy and a month after treatment ends About 2-3 teaspoons of blood will be collected for routine blood tests each time blood is drawn during this study Follow up CT scans or MRI scans will be done after every 2 to 3 cycles to evaluate your response to treatment
You will be taken off study if your disease gets worse or intolerable side effects occur If you have a complete response to this therapy no evidence of cancer then treatment will continue for an additional 6 months and then stop All treatment is given on an outpatient basis at UTMDACC
You will be monitored for at least 30 days after your last dose of therapy If you have side effects related to this treatment combination you will be monitored longer until the side effects have gone away
This is an investigational study Both gefitinib and topotecan are FDA approved and commercially available However their use together in this study is investigational A total of up to 52 patients will take part in this study All will be enrolled at UTMDACC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None