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

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Collaborator: Celgene Corporation
• Treatments: Albumin-Bound Paclitaxel; Azacitidine; Paclitaxel

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