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

This study has been completed.
Sponsor:
Information provided by:
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00083304
First received: May 18, 2004
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Metastases
Drug: Efaproxiral
Radiation: Whole Brain Radiation Therapy (WBRT)
Other: Supplemental Oxygen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Spectrum Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Measured from randomization until death due to any cause. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response Rate in the Brain at 3 Months [ Time Frame: Assessed at screening, 3 months after end of study treatment and at least 4 weeks after the 3-month scan. ] [ Designated as safety issue: No ]
  • Karnofsky Performance Status & Neurological Signs & Symptoms [ Time Frame: Assessed at baseline, 1 month follow-up (FU) visit, 3 month FU visit, and 6 month FU visit. ] [ Designated as safety issue: No ]

Enrollment: 368
Study Start Date: February 2004
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Efaproxiral + WBRT + Supplemental Oxygen 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.

Other Name: RSR13
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.

Active Comparator: WBRT + Supplemental Oxygen 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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult women with brain metastases from breast cancer
  • Minimum KPS of 70

Exclusion Criteria:

  • Previous treatment for brain metastases, including brain surgery and any form of radiation to the brain
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083304

  Show 94 Study Locations
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Investigators
Study Chair: John Suh, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Medical Monitor, Allos Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00083304     History of Changes
Other Study ID Numbers: RT-016
Study First Received: May 18, 2004
Last Updated: May 8, 2013
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Canada: Health Canada
Brazil: National Health Surveillance Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Croatia: Agency for Medicinal Product and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Peru: Instituto Nacional de Salud
Italy: The Italian Medicines Agency
Austria: Agency for Health and Food Safety
Lithuania: State Medicine Control Agency - Ministry of Health
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Chile: Instituto de Salud Pública de Chile

Keywords provided by Spectrum Pharmaceuticals, Inc:
Breast
Brain
RSR13
efaproxiral
Whole Brain Radiation Therapy
Brain metastases
Metastatic breast cancer

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Breast Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases
Efaproxiral
Antisickling Agents
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 22, 2014