Clinical Trials /

Ixabepilone and SBRT For Metastatic Breast Cancer

NCT01818999

Description:

This study is being done to find the effect of Stereotactic body radiation therapy (SBRT) in combination with Ixabepilone for women with triple negative metastatic breast cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Withdrawn

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Ixabepilone and SBRT For Metastatic Breast Cancer
  • Official Title: A Phase II Trial Of Ixabepilone and Stereotactic Body Radiation Therapy (SBRT) For Patients With Triple Negative Metastatic Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: STU 102012-020
  • NCT ID: NCT01818999

Conditions

  • METASTATIC BREAST CANCER

Interventions

DrugSynonymsArms
IXABEPILONEIxempraarm one

Purpose

This study is being done to find the effect of Stereotactic body radiation therapy (SBRT) in combination with Ixabepilone for women with triple negative metastatic breast cancer.

Detailed Description

      Ixabepilone is a FDA approved drug for the treatment of metastatic or locally advanced breast
      cancer after failure of chemotherapy. SBRT is a treatment method to deliver a high dose of
      radiation to the target, utilizing either a single dose or a small number of treatments with
      a high degree of precision within the body. The combination of Ixabepilone with SBRT is not
      an approved treatment at this time.
    

Trial Arms

NameTypeDescriptionInterventions
arm oneExperimentalIXABEPILONE and STEREOTACTIC BODY RADIATION THERAPY (SBRT)
  • IXABEPILONE

Eligibility Criteria

        Inclusion Criteria:

          1. Biopsy proven triple negative invasive ductal or lobular metastatic breast cancer.
             Tumor estrogen, progesterone, and HER2 (tested by IHC or FISH) negative disease. (ER-
             defined as </=1% by IHC, PR- defined as </=1% by IHC, and HER2- by IHC 1+. If HER2
             result by IHC is 2+ (equivocal), the tumor must be confirmed to be HER2- by FISH.

          2. Age ≥ 18 years.

          3. Patients must not have started Ixabepilone treatment more than 5 weeks prior to
             initiation of SBRT treatment.

          4. Patients can have up to 6 sites of active extracranial disease(</=3 in the liver = one
             site and </=3 in the lung= one site) identified by CT scan, or PET/CT, within 8 weeks
             prior to initiation of SBRT (up to 2 contiguous vertebral metastasis will be
             considered a single site of disease). Maximum number of lesions treated is deemed as
             feasible per the treating radiation oncologist; ie: A patient with 4 right axillary
             lymph nodes, L1-L2 bone metastasis, 3 lung lesions, 1 left lung lesion, 2 liver
             lesions, and T2-T3 bone metastasis would be defined as having 6 sites of disease.
             Criteria to define a lesion in any location as a metastasis requiring local treatment
             as one of the sites for SBRT is any lesion clinically felt to be viable; defined as
             enlarging on CT/MRI or having persistent FDG avidity (Either SUV>3 or increase of
             SUV>20% over a 6 month interval).

          5. Patients with skin nodules, skin invasion, or skin ulceration are eligible, if
             treatment with conventional radiation (at discretion of radiation oncologist) or
             surgery is planned. SBRT to skin nodules is not advised because of risk of skin
             necrosis.

          6. . Patients must have had failure of an anthracycline, a taxane and capecitabine as per
             FDA approved criteria.

          7. Performance status of ECOG 0,1, or 2.

          8. Adequate organ and marrow function as defined below:

               -  leukocytes ≥ 3,000/mcL

               -  absolute neutrophil count ≥ 1,500/mcL

               -  platelets ≥ 100,000/mcl

               -  total bilirubin within normal institutional limits

               -  AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit of normal

               -  creatinine within normal institutional limits

          9. Women of child-bearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry, for
             the duration of study participation, and for 90 days following completion of therapy.
             Should a woman become pregnant or suspect she is pregnant while participating in this
             study, she should inform her treating physician immediately.

             9.1 A female of child-bearing potential is any woman (regardless of sexual
             orientation, having undergone a tubal ligation, or remaining celibate by choice) who
             meets the following criteria:

               -  Has not undergone a hysterectomy or bilateral oophorectomy; or

               -  Has not been naturally postmenopausal for at least 12 consecutive months (i.e.,
                  has had menses at any time in the preceding 12 consecutive months).

         10. Patients who would be receiving SBRT for lung tumors who are known or must have a
             documented forced expiratory volume in 1 second (FEV1)>/=30%.

         11. Must have a CT C/A/P, or PET/CT scan within 8 weeks of enrollment.

         12. Ability to understand and the willingness to sign a written informed consent

        Exclusion Criteria:

          1. Patients may not be actively receiving any other investigational agents.

          2. Patients with untreated brain metastasis (patients can have whole brain radiation or
             stereotactic radiation to brain prior to enrollment).

          3. Patients with leptomeningeal disease.

          4. History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to Agent(s) used in study. Patients with a history of severe reactions to
             Cremephor EL or its derivatives (polyoxyethylated castor oil) are ineligible as
             Ixabepilone contraindicated in these patients

          5. Because the tolerance dose of SBRT to the gastrointestinal tract is not established,
             patients with metastatic disease invading the esophagus, stomach, intestines, or
             mesenteric lymph nodes will not be eligible.

          6. Patients with more than 6 discrete extra-cranial sites.

          7. Treatment for other carcinomas within the last 5 years, except cured non-melanoma skin
             and treated in-situ cancers.

          8. Patients must not be pregnant or nursing due to the potential for congenital
             abnormalities and the potential of this regimen to harm nursing infants.

          9. Patients must not be on concomitant CYP3A4 inhibitors or inducers (see section 4.3).
      
Maximum Eligible Age:99 Years
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:The effect of SBRT in combination with Ixabepilone on median progression free survival
Time Frame:5 years
Safety Issue:
Description:To evaluate the effect of SBRT in combination with Ixabepilone on median progression free survival. Progression free survival is defined as time from initiation of treatment to progressive disease or death

Secondary Outcome Measures

Measure:In-field local control and out-of field disease progression rates
Time Frame:5 years
Safety Issue:
Description:To describe the in-field local control and out-of field disease progression rates
Measure:Safety of SBRT in combination with Ixabepilone for patients with metastatic triple negative breast cancer after prior chemotherapy
Time Frame:1 year
Safety Issue:
Description:Evaluate the safety of SBRT in combination with Ixabepilone for patients with metastatic triple negative breast cancer after prior chemotherapy
Measure:The duration of Ixabepilone usage and time to initiation of next line systemic agent (chemotherapy or biologic agent)
Time Frame:5 year
Safety Issue:
Description:Evaluate the duration of Ixabepilone usage and time to initiation of next line systemic agent (chemotherapy or biologic agent)
Measure:Overall survival for patients with metastatic triple negative breast treated with SBRT in combination with Ixabepilone
Time Frame:5 year
Safety Issue:
Description:Evaluate overall survival for patients with metastatic triple negative breast treated with SBRT in combination with Ixabepilone
Measure:Generation of an immune response to tumor cells
Time Frame:1 year
Safety Issue:
Description:Evaluate generation of an immune response to tumor cells

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:University of Texas Southwestern Medical Center

Trial Keywords

  • METASTATIC BREAST CANCER

Last Updated

October 23, 2015