None listed
Conditions
Interventions
Group A Type of group
Patients assigned to Treatment Group A will receive efaproxiral and O2 complement within 30 minutes prior to daily WBRT.
Group name:Group B Type of group
Patients assigned to Treatment Group B will receive a 02 supplement and WBRT.
Sponsors
ALLOS THERAPEUTICS, INC.,
Eligibility
Inclusion criteria
Inclusion criteria: • Histologically or cytologically confirmed breast cancer in women with brain metastases confirmed radiographically. • Must be at least 18 years of age. • KPS> 70. • Adequate renal, hepatic and hematological function. • Proper pulmonary function tests. • Saturation of arterial O2 at rest measured by means of cutaneous pulse oximetry (Sp02)> 90% when breathing ambient air. • Sp02 in activity (for example, uninterrupted walk for approximately 50 feet [15 m] on a flat surface)> 90% when breathing ambient air. • Women with a capacity to procreate should practice a medically acceptable contraceptive regimen and must obtain a negative serum pregnancy test within 14 days prior to the first day of WRBT. Postmenopausal patients for at least 1 year (> 12 months since the last menstrual period) or who are surgically sterilized should not undergo this test. • The patient must be available to repeat the dose and to receive follow-up. • The patient must give her informed consent in writing.
Exclusion criteria
Exclusion criteria: • Active concurrent malignant disease (except non-melanoma skin cancer or cervical carcinoma in-situ). If there is a history of previous malignancy, the patient should not have been exposed to the disease for> 5 years. • The patient is likely to undergo surgical removal and / or stereotactic radiosurgery as an initial therapy for brain metastasis. • Planned concurrent systemic treatment (cytotoxic and / or cytostatic) for breast cancer and / or extracranial metastasis during WBRT, with the exception of hormonal therapy, with trastuzumab and / or with corticosteroids. • Previous treatment for brain metastasis (includes external beam radiotherapy, brachytherapy, stereotactic radiography, surgery, chemotherapy and treatments with drugs, biological substances or devices under investigation). • Presence of leptomeningeal metastasis. • Use of any drug, biological substance or device under investigation within 28 days prior to day 1 of WBRT. • Previous exposure to efaproxiral. • Pregnant or lactating women. • Active infection or any serious pre-existing medical condition, which could affect the patient´s ability to receive the protocol treatment. • Dementia or mental state significantly altered that would hinder understanding and the granting of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The overall survival between the treatment groups will be compared by means of the stratified registry classification test. The strata that are used in this test will coincide with the strata that had been defined at the moment of the random assignment of the patients. Survival will be measured from the random assignment date. Measure:Survival Timepoints:After treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The response rate in the brain at 3 months will be evaluated through a blind central review based on the criteria proposed by the RECIST Committee Measure:Response rate in the brain at 3 months Timepoints:3 months ; Outcome name:The KPS of each patient will be analyzed in the initial visit and in the follow-up visits of month 1, month 3 and month 6. The percentage of patients with stable KPS classifications or improvement (relative to the initial visit) will be compared. between one and another treatment groups. Measure:KPS and evaluation of neurological signs and symptoms Timepoints:month 1, month 3 and month 6 | — |
Countries
Austria, Hungary, Italy, Lithuania, Spain, United Kindgdom
Outcome results
None listed