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Study of Neoadjuvant Chemotherapy With Nanoparticle Albumin Bound Paclitaxel, Doxorubicin and Cyclophosphamide (NAC) in Patients With Stages II-III Breast Cancer

This study is currently recruiting participants.
Verified April 2013 by University of Utah
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01090128
First received: March 17, 2010
Last updated: April 10, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this clinical trial is to test whether treatment of patients with breast cancer with the combination of Abraxane (nab-paclitaxel), Adriamycin (doxorubicin), and Cyclophosphamide prior to surgery is safe and results in good tumor response. Up to 24 patients may be enrolled in this study at the Mitchell Cancer Institute. All patients enrolling in this study will receive treatment with the combination of Abraxane, Adriamycin, and Cyclophosphamide.


Condition Intervention Phase
Stages II-III Breast Cancer
 Drug: Nanoparticle Albumin Bound Paclitaxel
Drug: doxorubicin
Drug: cyclophosphamide
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Neoadjuvant Chemotherapy With Nanoparticle Albumin Bound Paclitaxel, Doxorubicin and Cyclophosphamide (NAC) in Patients With Stages II-III Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Type, incidence, severity, timing, seriousness and relatedness of adverse events and laboratory abnormalities [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall clinical response rate (OcRR) [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: September 2008
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All patients
All participants enrolled.
 Drug: Nanoparticle Albumin Bound Paclitaxel
IV administered over 30 minutes. The study will test four dose levels.
Other Name: Abraxane
Drug: doxorubicin
50 mg/m2 every 3 weeks
Other Name: Adriamycin
Drug: cyclophosphamide
500 mg/m2 given every 3 weeks

Detailed Description:

This is a single center, open phase I dose escalation study. This study will assess the highest tolerable dose of nab-paclitaxel (Abraxane) in combination with doxorubicin (Adriamycin) and cyclophosphamide in patients with stages II-III breast cancer in the neoadjuvant setting. The objective is to primarily assess the safety of the drug combination, and to secondarily obtain preliminary data on the clinical efficacy of the combination. Up to 24 patients will be enrolled.

The study will test four dose levels of Abraxane as described in Table 2, with fixed dose of doxorubicin (50 mg/m2 weekly) and cyclophosphamide (500 mg/m2). For each cycle, Abraxane will be administered based on the dose schedule in Table 2. Adriamycin and Cyclophosphamide will be given on day 1 and day 22 of each cycle. Each cycle will be repeated every 6 weeks. The study will enroll patients with stages II-III, Her-2 negative breast cancer with no prior therapy. Patients will be treated for 3 six-week cycles, for a total of 18 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically or cytologically proven adenocarcinoma of the breast stages II-III, according to the AJCC Staging Manual, 6th Edition, 2002
  2. Negative Her-2/neu status
  3. ECOG performance status 0 or 1
  4. Negative pregnancy test
  5. Normal cardiac function (ejection fraction > lower limit of normal) as determined by MUGA or echocardiogram
  6. ANC greater than or equal to 1,500/mm3; platelet greater than or equal to 100,000/mm3; hemoglobin greater than or equal to 9 gm/dL
  7. Serum bilirubin levels less than or equal to 1.5 mg/dL
  8. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) less than or equal to 2.5 X upper limit of normal, alkaline phosphatase less than or equal to 2.5 X upper limit of normal.
  9. Serum creatinine levels less than or equal to 1.5 mg/dL
  10. 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. Appropriate methods of birth controls for women include oral or implanted contraceptives, intrauterine device (IUD), diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner and also based on the judgment of the investigator.
  11. Female, greater than or equal to 19 years of age and any race.

Exclusion Criteria:

  1. Evidence of metastatic disease
  2. Concurrent therapy with any other non-protocol anti-cancer therapy
  3. Current therapy with hormone replacement therapy, or any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators
  4. Presence of neuropathy > grade 2 (NCI-CTC version 3.0) at baseline
  5. History of any other malignancy requiring active treatment
  6. Clinically significant cardiovascular disease (e.g., hypertension [BP > 150/100], myocardial infarction or stroke within 6 months, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
  7. Currently active infection.
  8. History of HIV infection or chronic hepatitis B or C.
  9. The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of the drugs in this protocol or place the subject at undue risk for treatment complications
  10. Pregnancy or breast feeding
  11. A history of a severe hypersensitivity reaction to nab-paclitaxel.
  12. Any reason why, in the opinion of the investigator, the patient should not participate.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01090128

Contacts
Contact: Emily Ostrander 801-587-4567 emily.ostrander@hci.utah.edu
Contact: Candace Larson 801-213-4241 candace.larson@hci.utah.edu

Locations
United States, Utah
University of Utah Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Candace Larson, CCRP     801-213-4241     candace.larson@hci.utah.edu    
Principal Investigator: Hung T Khong, MD            
Sponsors and Collaborators
University of Utah
Celgene Corporation
Investigators
Principal Investigator: Hung Khong, MD University of Utah
  More Information

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01090128     History of Changes
Other Study ID Numbers: HCI53989
Study First Received: March 17, 2010
Last Updated: April 10, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Doxorubicin
Paclitaxel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
 Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on June 18, 2013