Clinical trial NCT00748553: A Phase I/II Clinical Trial of Vidaza With Abraxane in Patients With Advanced/Metastatic Solid Tumors and Breast Cancer
Official title: A Phase I/II Clinical Trial of the Hypomethylating Agent Azacitidine (Vidaza) With the Nanoparticle Albumin Bound Paclitaxel (Abraxane) in the Treatment of Patients With Advanced or Metastatic Solid Tumors and Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced or Metastatic Solid Tumors
Advanced or Metastatic Breast Cancer
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2008-09-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 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 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

Primary outcomes:
measure: Phase I: Percentage of Participants Responding to Treatment
timeFrame: 6 months
measure: Phase II: Percentage of Participants With Objective Response Rate (ORR) Measured Using RECIST 1.0 Criteria
timeFrame: 1.5 years
Secondary outcomes:
measure: Number of Participants With ER+ Status
timeFrame: 2 years
measure: Progression-free Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: University of Utah
name: Hung T Khong, MD
role: PRINCIPAL_INVESTIGATOR
References: