A Phase I/II Clinical Trial of Vidaza With Abraxane in Patients With Advanced/Metastatic Solid Tumors and Breast Cancer (VA)
|Advanced or Metastatic Solid Tumors Advanced or Metastatic Breast Cancer||Drug: Azacitidine (Vidaza) Drug: Nab-paclitaxel (Abraxane)||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- Phase I: Percentage of Participants Responding to Treatment [ Time Frame: 6 months ]Azacitidine is set at 75mg/m2 and Nab-paclitaxel is set at100mg/m2 based on the number of participants responding to treatment as measured per RECIST v1 criteria.
- Phase II: Percentage of Participants With Objective Response Rate (ORR) Measured Using RECIST 1.0 Criteria [ Time Frame: 1.5 years ]
Objective response rate (ORR) will be measured using RECIST 1.0 criteria. The best response, including complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD), for each patient will be summarized.
For target lesions, Complete Response is defined as disappearance of all target lesions for at least 4 weeks; Partial Response consists of at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD, for at least 4 weeks; Progressive Disease consists of at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease consists of neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
- Number of Participants With ER+ Status [ Time Frame: 2 years ]Tissue SPARC protein will be assessed using archival tumor blocks. In addition, in patients who have easily accessible tumors, such as lymph nodes, cutaneous or subcutaneous lesions, and who have consented to sample collection, biopsies will be taken twice: before cycle 1 day 1 treatment, and cycle 3 day 8 (+/- 3 days).
- Progression-free Survival [ Time Frame: 2 years ]Progression-free survival (PSF) is defined as the length of time during and after treatment in which a patient is living with a disease that does not get worse.
|Study Start Date:||September 2008|
|Study Completion Date:||October 2015|
|Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Experimental: All patients
All participants enrolled.
Drug: Azacitidine (Vidaza)
50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle
Other Name: VidazaDrug: Nab-paclitaxel (Abraxane)
100mg/m2 weekly for 3 weeks of each 4-week cycle
Other Name: Abraxane
Please refer to this study by its ClinicalTrials.gov identifier: NCT00748553
|United States, Utah|
|University of Utah Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Hung T Khong, MD||University of Utah|