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

NCT00748553 | Completed Phase 1 Results

• 1 other identifier: HCI53993
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced or Metastatic Solid Tumors; Advanced or Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Phase I: Percentage of Participants Responding to Treatment

  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.

  6 months

• Phase II: Percentage of Participants With Objective Response Rate (ORR) Measured Using RECIST 1.0 Criteria

  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.

  1.5 years

Secondary Outcomes (2)

• Number of Participants With ER+ Status

  2 years

• Progression-free Survival

  2 years

Study Arms (1)

All patients

EXPERIMENTAL

All participants enrolled.

Drug: Azacitidine (Vidaza); Drug: Nab-paclitaxel (Abraxane)

Interventions

Azacitidine (Vidaza) DRUG

50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle

Also known as: Vidaza

All patients

Nab-paclitaxel (Abraxane) DRUG

100mg/m2 weekly for 3 weeks of each 4-week cycle

Also known as: Abraxane

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• For phase II, pathologically confirmed breast cancer, measurable disease, no prior treatments for recurrent or metastatic breast cancer.
• Her-2/neu negative (Phase II)
• Negative pregnancy test for female subjects
• 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.
• Male or female for phase I and female for phase II, \>19 years of age and any race.

You may not qualify if:

• Major surgery, radiotherapy, chemotherapy or investigational agents within 4 weeks of treatment day 1
• Known brain metastases
• Prior taxanes (except for adjuvant therapy more than 6 months prior to treatment day 1) (phase II)
• Active infection requiring antibiotic therapy
• History of allergy or hypersensitivity to nab-paclitaxel, albumin or a taxane
• Grade 2 or greater motor or sensory neuropathy
• Prior cytotoxic chemotherapy for recurrent or metastatic breast cancer (phase II portion)
• 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.
• Known or suspected hypersensitivity to azacitidine or mannitol
• Pregnant or breast feeding
• Patients with advanced malignant hepatic tumors
• Malignancy other than breast carcinoma (phase II)
• Known HIV infection or chronic hepatitis B or C

Sponsors & Collaborators

• University of Utah: lead
• Celgene Corporation: collaborator

Study Sites (1)

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Azacitidine; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Kimberlee Taylor
• Organization: Huntsman Cancer Institute

Kimberlee.Taylor@hci.utah.edu

8012135673

Study Officials

• Hung T Khong, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2008
• First Posted: September 8, 2008
• Study Start: September 1, 2008
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: July 26, 2017
• Results First Posted: July 26, 2017

Record last verified: 2017-06

Locations

US (1)