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Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer

NCT00083304 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 368

Last updated 2013-05-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Efaproxiral

75 mg/kg, administered over 30 minutes via a central venous access device (CVAD). Administered 30 minutes prior to the start of whole brain radiation therapy (WBRT) on each WBRT treatment day for 10 days.

RADIATION

Whole Brain Radiation Therapy (WBRT)

3.0 Gy per day for 10 days (30.0 Gy total) of WBRT.

OTHER

Supplemental Oxygen

4 L/minute by nasal cannula. Administered at least 35 minutes prior to WBRT, during WBRT and until 15 minutes after completion of WBRT on all WBRT treatment days.

Sponsors & Collaborators

  • Spectrum Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • John Suh, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2007-06-30
Completion
2007-06-30

Countries

  • United States
  • Argentina
  • Austria
  • Brazil
  • Canada
  • Chile
  • Croatia
  • France
  • Greece
  • Hungary
  • Italy
  • Lithuania
  • Peru
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00083304 on ClinicalTrials.gov