Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00230542
Status:
COMPLETED
Last Update Posted:
2018-08-13
First Post:
2005-09-29
Brief Title:
Carboplatin and Pemetrexed in Recurrent Platinum Sensitive Ovarian Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase II Study of Carboplatin and Pemetrexed in Patients With Recurrent Platinum Sensitive Ovarian Fallopian Tube or Primary Peritoneal Cancer
Status:
COMPLETED
Status Verified Date:
2018-08
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 purpose of this study is to determine the effects good and bad the combination of carboplatin and pemetrexed have on patients with recurrent ovarian peritoneal or fallopian tube cancer
Detailed Description:
Before patients receive any chemotherapy treatments they will be given three medications to prevent side effects from the chemotherapy drugs These medications are vitamin B12 folic acid and dexamethasone
Chemotherapy treatments will be given intravenously in the outpatient clinic Pemetrexed will be given first and will take 10 minutes to infuse followed by carboplatin which will take 30-45 minutes to infuse These treatments will be repeated once every three weeks for 6 cycles of chemotherapy 18 weeks
Before each chemotherapy treatment the following tests and procedures will be performed physical exam and medical history evaluation of ability to undertake daily activities and blood tests
After every 2 cycles of chemotherapy every 6 weeks patients will have a CT or MRI scan to measure how well their cancer is responding to treatment
The study treatment will last for 6 cycles of chemotherapy as long as the tumor does not grow and the patient isnt experiencing any severe side effects
Chemotherapy treatments will be given intravenously in the outpatient clinic Pemetrexed will be given first and will take 10 minutes to infuse followed by carboplatin which will take 30-45 minutes to infuse These treatments will be repeated once every three weeks for 6 cycles of chemotherapy 18 weeks
Before each chemotherapy treatment the following tests and procedures will be performed physical exam and medical history evaluation of ability to undertake daily activities and blood tests
After every 2 cycles of chemotherapy every 6 weeks patients will have a CT or MRI scan to measure how well their cancer is responding to treatment
The study treatment will last for 6 cycles of chemotherapy as long as the tumor does not grow and the patient isnt experiencing any severe side effects
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