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

Sponsored by University of South Alabama

Phase Quota
Phase 1

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.

Study Start Date: September 2008

Estimated Completion Date: November 2016

Specialties: Obstetrics & Gynecology: Breast Family Medicine: Women`s Health Oncology: Breast Physician Assistant: Hematology/Oncology,Obstetrics/Gynecology


  • Drug: Azacitidine (Vidaza)
  • Drug: Nab-paclitaxel (Abraxane)

Inclusion criteria

  • 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
  • For phase II, pathologically confirmed breast cancer, measurable disease, no prior treatments for recurrent or metastatic breast cancer
  • Her-2/neu negative (Phase II)
  • Negative pregnancy test for female subjects
  • 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
  • Male or female for phase I and female for phase II, >19 years of age and any race

Exclusion criteria

  • Major surgery, radiotherapy, chemotherapy or investigational agents within 4 weeks of treatment day 1
  • Known brain or leptomeningeal metastases
  • Prior taxanes (except for adjuvant therapy more than 6 months prior to treatment day 1) (phase II)
  • Active infection requiring antibiotic therapy
  • History of allergy or hypersensitivity to nab-paclitaxel, albumin or a taxane
  • Grade 2 or greater motor or sensory neuropathy
  • Prior cytotoxic chemotherapy for recurrent or metastatic breast cancer (phase II portion)
  • 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.
  • Known or suspected hypersensitivity to azacitidine or mannitol
  • Pregnant or breast feeding
  • Patients with advanced malignant hepatic tumors
  • Malignancy other than breast carcinoma (phase II)
  • Known HIV infection or chronic hepatitis B or C

Study Locations And Contact Information

  • University of Utah Huntsman Cancer Institute, Salt Lake City Utah

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