Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083304
Status:
COMPLETED
Last Update Posted:
2013-05-10
First Post:
2004-05-18
Brief Title:
Whole Brain Radiation Therapy With Oxygen With or Without RSR13 in Women With Brain Metastases From Breast Cancer
Sponsor:
Spectrum Pharmaceuticals Inc
Organization:
Spectrum Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 3 Randomized Open-label Comparative Study of Standard Whole Brain Radiation Therapy With Supplemental Oxygen With or Without Concurrent RSR13 Efaproxiral in Women With Brain Metastases From Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-05
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:
ENRICH
Brief Summary:
RSR13 efaproxiral is a radiation sensitizer that has shown positive results in a Phase 3 randomized clinical trial of patients with brain metastases Of 111 eligible breast cancer patients with brain metastases in that trial 59 patients who received RSR13 prior to radiation therapy had a median survival time that was twice as long as the 52 patients who did not receive RSR13 prior to radiation therapy
RSR13 efaproxiral is an experimental drug that increases the amount of oxygen released from blood into the tissues It is well known that certain types of cancer tumors including those in brain metastases lack oxygen Lack of oxygen in a tumor can reduce the effect of radiation therapy RT RSR13 may increase the oxygen level in brain tumors so that radiation therapy works better
This study will enroll up to 360 women with brain metastases from breast cancer and will evaluate if whole brain radiation therapy given with RSR13 will have a better treatment effect than whole brain radiation therapy alone RSR13 will be infused intravenously IV through a central catheter placed in a central vein Women randomized assigned to receive RSR13 therefore will need to have a central catheter placed for treatment unless one is already in place
RSR13 efaproxiral is an experimental drug that increases the amount of oxygen released from blood into the tissues It is well known that certain types of cancer tumors including those in brain metastases lack oxygen Lack of oxygen in a tumor can reduce the effect of radiation therapy RT RSR13 may increase the oxygen level in brain tumors so that radiation therapy works better
This study will enroll up to 360 women with brain metastases from breast cancer and will evaluate if whole brain radiation therapy given with RSR13 will have a better treatment effect than whole brain radiation therapy alone RSR13 will be infused intravenously IV through a central catheter placed in a central vein Women randomized assigned to receive RSR13 therefore will need to have a central catheter placed for treatment unless one is already in place
Detailed Description:
The screening process will include documentation of the cancer which which will require a brain scan and may include a liver scan Other screening measurements will include a Karnofsky Performance Status KPS assessment measurement of the amount of oxygen in the blood using a non-invasive device most often placed on the finger lung function tests that will require blowing into a machine and an electrocardiogram ECG About 2 teaspoons or 10 mL of blood will be taken for specific laboratory tests and a pregnancy test will be done on the blood of women of childbearing potential
All study patients will receive supplemental oxygen and whole brain radiation therapy WBRT 30 Gy 3 Gy fractions every weekday for 2 weeks Half of the patients will be randomized assigned to receive RSR13 prior to WBRT and will need to have a central catheter placed for treatment unless one is already in place Patients who receive RSR13 will also need to continue to receive oxygen in the clinic until the amount of oxygen in their blood is near normal This level has returned to near normal in most patients within 1 to 2 hours
During treatment and follow-up visits physical and neurological exam KPS assessment weight height and vital sign measurements and about 2 teaspoons of blood may be required Patients will need to return for follow-up visits 1 month after completion of treatment 2 months later and every 3 months thereafter until their doctor tells them otherwise
All study patients will receive supplemental oxygen and whole brain radiation therapy WBRT 30 Gy 3 Gy fractions every weekday for 2 weeks Half of the patients will be randomized assigned to receive RSR13 prior to WBRT and will need to have a central catheter placed for treatment unless one is already in place Patients who receive RSR13 will also need to continue to receive oxygen in the clinic until the amount of oxygen in their blood is near normal This level has returned to near normal in most patients within 1 to 2 hours
During treatment and follow-up visits physical and neurological exam KPS assessment weight height and vital sign measurements and about 2 teaspoons of blood may be required Patients will need to return for follow-up visits 1 month after completion of treatment 2 months later and every 3 months thereafter until their doctor tells them otherwise
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