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

Advanced or Metastatic Solid Tumors Clinical Trial

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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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00748553
• Other study ID #: HCI53993
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 4, 2008
• Last updated: September 14, 2016
• Start date: September 2008
• Est. completion date: October 2015

Study information

• Verified date: September 2016
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced or Metastatic Breast Cancer
• Advanced or Metastatic Solid Tumors
• Breast Neoplasms

Intervention

Drug:
• Azacitidine (Vidaza)
50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle
• Nab-paclitaxel (Abraxane)
100mg/m2 weekly for 3 weeks of each 4-week cycle

Locations

Country	Name	City	State
United States	University of Utah Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I: To assess safety of Vidaza and Abraxane combination and to select the recommended phase II dose-regimen		6 months	Yes
Primary	Phase II: To assess clinical efficacy of Vidaza and Abraxane combination		1.5 years	Yes
Secondary	To explore the relationship between specific biomarkers and cancer- and treatment-related outcomes;		2 years	No
Secondary	To assess progression-free survival.		2 years	No