Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Active 19 and over Other VAST-B NCT00748553

Trial Description

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.

Further Study Information

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.

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 or leptomeningeal 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

Trial Contact Information

Trial Lead Organizations/Sponsors

University of South Alabama Mitchell Cancer Institute

Hung T Khong, MD

Principal Investigator

Pam Francisco, CCRP		Ph: 251-665-8000
		Email: pfrancisco@usouthal.edu

Marion Long, RN		Ph: 251-665-8000
		Email: long@usouthal.edu

U.S.A.
Alabama
	Mobile
	University of South Alabama Mitchell Cancer Institute
		Pam Francisco, CCRP	Ph: 251-665-8000
			Email: pfrancisco@usouthal.edu
		Marion Long, RN	Ph: 251-665-8000
			Email: long@usouthal.edu

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00748553
Information obtained from ClinicalTrials.gov on September 23, 2008