Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00418093
Status:
TERMINATED
Last Update Posted:
2014-06-19
First Post:
2007-01-02
Brief Title:
Oxaliplatin Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Evaluation of Oxaliplatin Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma
Status:
TERMINATED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
THe study was terminated early due to a lack of accural
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this study is to begin to collect information and try to learn whether or not the combination of oxaliplatin gemcitabine and bevacizumab works in treating women with recurrent mullerian carcinoma We will also collect more information about the safety and side effects of this combination of drugs Gemcitabine and oxaliplatin are chemotherapy drugs that kill cancer cells Bevacizumab is a new anti-cancer drug that works to slow or stop cell growth in cancerous tumors by decreasing the blood supply to the tumors
Detailed Description:
The study treatment is divided into periods called cycles Each cycle is 28 days long Participants will be given the study drugs intravenously on day 1 and day 15 of each cycle
Gemcitabine will be given first over a period of 30 minutes Then oxaliplatin over a period of 2 hours Finally bevacizumab will be given over a period of 30 to 90 minutes Participants will continue study treatment as long as their tumor is not growing and they are not experiencing unacceptable side effects If the tumor goes away completely the participant will have 2 more cycle of study treatment
Blood will be drawn for routine testing every week during study treatment to check for side effects Before day 1 and 15 of each cycle the following tests and procedures will be performed a medical history complete physical exam vital signs blood tests and urine tests Before day 1 of every other cycle the following additional procedures will be performed A CT scan x-ray or ultrasound of your abdomen and pelvis an x-ray of the chest if required by the study doctor blood tests and urine samples
If the participants tumor goes away they will be asked to return to the clinic for follow-up visits every 3 months for 2 years then every 6 months for 3 years At each follow-up visit the following tests and procedures will be performed medical history complete physical examination CT scan x-ray or ultrasound of the abdomen and pelvis x-ray of the chest and other tests if the doctor feels they are needed
There is an optional sub-study that six subjects will be asked to take a part in that will give the study doctors important information about the way the body uses and breaks down the study drugs This sub-study will involve special surgical procedures and scans that will be done during cycle 1 of the study treatment
Gemcitabine will be given first over a period of 30 minutes Then oxaliplatin over a period of 2 hours Finally bevacizumab will be given over a period of 30 to 90 minutes Participants will continue study treatment as long as their tumor is not growing and they are not experiencing unacceptable side effects If the tumor goes away completely the participant will have 2 more cycle of study treatment
Blood will be drawn for routine testing every week during study treatment to check for side effects Before day 1 and 15 of each cycle the following tests and procedures will be performed a medical history complete physical exam vital signs blood tests and urine tests Before day 1 of every other cycle the following additional procedures will be performed A CT scan x-ray or ultrasound of your abdomen and pelvis an x-ray of the chest if required by the study doctor blood tests and urine samples
If the participants tumor goes away they will be asked to return to the clinic for follow-up visits every 3 months for 2 years then every 6 months for 3 years At each follow-up visit the following tests and procedures will be performed medical history complete physical examination CT scan x-ray or ultrasound of the abdomen and pelvis x-ray of the chest and other tests if the doctor feels they are needed
There is an optional sub-study that six subjects will be asked to take a part in that will give the study doctors important information about the way the body uses and breaks down the study drugs This sub-study will involve special surgical procedures and scans that will be done during cycle 1 of the study treatment
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