Status:
COMPLETED
A Phase I/II Clinical Trial of Vidaza With Abraxane in Patients With Advanced/Metastatic Solid Tumors and Breast Cancer
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Celgene Corporation
Conditions:
Advanced or Metastatic Solid Tumors
Advanced or Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 respon...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00748553
Start Date
September 1 2008
End Date
October 1 2015
Last Update
July 26 2017
Active Locations (1)
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1
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112