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A Phase I/II Clinical Trial of Vidaza With Abraxane in Patients With Advanced/Metastatic Solid Tumors and Breast Cancer

NCT00748553

Description:

The purpose of this clinical trial is to test whether treatment of patients with advanced or metastatic solid tumors or breast cancer with Abraxane plus Vidaza is safe and results in good tumor response. All patients enrolling in this study will receive treatment with Abraxane and Vidaza. Safety will be assessed by adverse events, laboratory results and performance status. Tumor response will be measured by RECIST criteria.

Related Conditions:
  • Breast Carcinoma
  • Lymphoma
  • Malignant Solid Tumor
Recruiting Status:

Completed

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Phase I/II Clinical Trial of Vidaza With Abraxane in Patients With Advanced/Metastatic Solid Tumors and Breast Cancer
  • Official Title: A Phase I/II Clinical Trial of the Hypomethylating Agent Azacitidine (Vidaza) With the Nanoparticle Albumin Bound Paclitaxel (Abraxane) in the Treatment of Patients With Advanced or Metastatic Solid Tumors and Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: HCI53993
  • NCT ID: NCT00748553

Conditions

  • Advanced or Metastatic Solid Tumors
  • Advanced or Metastatic Breast Cancer

Interventions

DrugSynonymsArms
Azacitidine (Vidaza)VidazaAll patients
Nab-paclitaxel (Abraxane)AbraxaneAll patients

Purpose

The purpose of this clinical trial is to test whether treatment of patients with advanced or metastatic solid tumors or breast cancer with Abraxane plus Vidaza is safe and results in good tumor response. All patients enrolling in this study will receive treatment with Abraxane and Vidaza. Safety will be assessed by adverse events, laboratory results and performance status. Tumor response will be measured by RECIST criteria.

Detailed Description

      The phase I part of the study will enroll patients with advanced or metastatic solid tumors
      who have failed at least one previous treatment. The purpose of the phase I part is to assess
      the safety of the investigational treatment and select the recommended phase II dose-regimen.
      The phase II part of the study will enroll patients with advanced or metastatic HER2-negative
      breast cancer who have not received treatment for their metastatic disease. The purpose of
      the phase II part of the study is to assess safety and efficacy of the investigational
      treatment in breast cancer. The study doctor will determine what phase patients will be
      enrolled in.
    

Trial Arms

NameTypeDescriptionInterventions
All patientsExperimentalAll participants enrolled.
  • Azacitidine (Vidaza)
  • Nab-paclitaxel (Abraxane)

Eligibility Criteria

        Inclusion Criteria:

          1. For phase I, any solid tumors, including lymphoma, that progressed or were stable as
             best response on at least one previous therapy and are evaluable.

          2. For phase II, pathologically confirmed breast cancer, measurable disease, no prior
             treatments for recurrent or metastatic breast cancer.

          3. Her-2/neu negative (Phase II)

          4. Negative pregnancy test for female subjects

          5. Women of childbearing potential should be advised to avoid becoming pregnant and men
             should be advised to not father a child while receiving treatment with azacitidine or
             nab-paclitaxel. investigator.

          6. Male or female for phase I and female for phase II, >19 years of age and any race.

        Exclusion Criteria:

          1. Major surgery, radiotherapy, chemotherapy or investigational agents within 4 weeks of
             treatment day 1

          2. Known brain metastases

          3. Prior taxanes (except for adjuvant therapy more than 6 months prior to treatment day
             1) (phase II)

          4. Active infection requiring antibiotic therapy

          5. History of allergy or hypersensitivity to nab-paclitaxel, albumin or a taxane

          6. Grade 2 or greater motor or sensory neuropathy

          7. Prior cytotoxic chemotherapy for recurrent or metastatic breast cancer (phase II
             portion)

          8. Uncontrolled hypertension, arrhythmia, congestive heart failure or angina. Patients
             who have had a myocardial infarction or cardiac surgery should be at least 6 months
             from the event and free of active symptoms.

          9. Known or suspected hypersensitivity to azacitidine or mannitol

         10. Pregnant or breast feeding

         11. Patients with advanced malignant hepatic tumors

         12. Malignancy other than breast carcinoma (phase II)

         13. Known HIV infection or chronic hepatitis B or C
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Phase I: Percentage of Participants Responding to Treatment
Time Frame:6 months
Safety Issue:
Description:Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2 based on the number of participants responding to treatment as measured per RECIST v1 criteria.

Secondary Outcome Measures

Measure:Number of Participants With ER+ Status
Time Frame:2 years
Safety Issue:
Description:Tissue SPARC protein will be assessed using archival tumor blocks. In addition, in patients who have easily accessible tumors, such as lymph nodes, cutaneous or subcutaneous lesions, and who have consented to sample collection, biopsies will be taken twice: before cycle 1 day 1 treatment, and cycle 3 day 8 (+/- 3 days).
Measure:Progression-free Survival
Time Frame:2 years
Safety Issue:
Description:Progression-free survival (PSF) is defined as the length of time during and after treatment in which a patient is living with a disease that does not get worse.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:University of Utah

Last Updated

June 27, 2017