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

Completed · Phase 1/Phase 2

Conditions studied: Advanced or Metastatic Solid Tumors, Advanced or Metastatic Breast Cancer

In brief

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.

Key facts

Study ID

NCT00748553

Run by

University of Utah

People needed

30

Starts

2008-09-01

Expected to finish

2015-10-01

Last updated by the study team

2017-07-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Major surgery, radiotherapy, chemotherapy or investigational agents within 4 weeks of treatment day 1
• Known brain 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

Where it is running

• University of Utah Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.