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Abraxane, Avastin, and Gemcitabine as First-Line Therapy for Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00503906
First Posted: July 19, 2007
Last Update Posted: May 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Miami
  Purpose
The investigators hypothesize that the combination of Gemzar®, Abraxane® and Avastin will increase the progression-free survival (PFS) in patients with first line metastatic breast cancer and in patients who received neoadjuvant and/or adjuvant chemotherapy present with definable metastatic disease, 6 or more months after primary treatment.

Condition Intervention Phase
Breast Cancer Drug: Avastin Drug: Gemcitabine Drug: Abraxane Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Abraxane, Avastin and Gemcitabine for First Line Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Median Progression-Free Survival [ Time Frame: Up to 24 months ]
    Progression-free survival will be measured from the first dose date to the earliest date of documented evidence of progressive disease or the date of death due to any causes, whichever occurs first.


Secondary Outcome Measures:
  • Rates of Partial Response (PR), Complete Response (CR) and Overall Response (ORR) in Study Participants [ Time Frame: After two cycles, about 60 days ]
    Rates of partial response (PR), complete response (CR) and overall response (PR+CR = ORR) in study participants according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0.

  • Rate of Toxicity in Study Participants [ Time Frame: Over the course of study treatment. ]
    Determination of safety and side effect profile of the protocol therapy including the rate of toxicity in study participants. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for adverse event reporting.

  • Relationship Between Circulating Tumor Cells (CTC) and Disease Progression as Measured by Presence of CTC at Baseline and Over the Course of Study Treatment [ Time Frame: Baseline, over the course of Treatment, about 1 year ]
    Exploration of the relationship between circulating tumor cells (CTC) and disease progression, by measuring CTC at baseline and over the course of treatment.

  • Relationship Between SPARC Expression and Response to Protocol Therapy. [ Time Frame: Baseline, over the course of treatment, about 1 year ]
    Relationship between SPARC expression and response to this chemotherapy combination and relation to progression free survival.


Enrollment: 30
Study Start Date: June 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abraxane, Avastin and Gemcitabine

Each treatment cycle is 28 days. Participants will be treated until disease progression:

  • Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
  • Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by;
  • Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.
Drug: Avastin
Other Name: Bevacizumab
Drug: Gemcitabine
Other Name: Gemzar
Drug: Abraxane
Other Name: Albumin-Bound Paclitaxel Formulation

Detailed Description:
This is a phase 2, single arm study. Participants will be treated with combination Gemzar, Abraxane and Avastin therapy until disease progression. Each treatment cycle is 28 days.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Patients must either be:

    • treatment-naïve with newly diagnosed her2neu non-overexpressing (non amplified) metastatic (Stage IV) breast cancer, or
    • HER2/neu-negative patients with metastasis diagnosed 6 or more months after completing primary systemic treatment (neoadjuvant, adjuvant chemotherapy).
  2. No previous chemotherapy regimen for metastatic breast cancer.
  3. 18 years of age or older.
  4. Measurable disease as defined by RECIST criteria or evaluable disease.
  5. Eastern Cooperative Oncology Group (ECOG) 0-1.
  6. Life expectancy greater than 3 months.
  7. For female (or male) patients, either pre- or post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control for the duration of the study
  8. Provide written informed consent before any study-related procedure not part of normal medical care is conducted
  9. Willing and able to comply with the protocol requirement
  10. Laboratory parameters as follows:

    • Neutrophils: 1.5 x109/L or greater
    • Platelets: 100 x109/L or greater
    • Hemoglobin: ≥ 9.0 g/dL
    • Serum Creatinine: ≤ 1.5mg/dL
    • Bilirubin: ≤ ULN, except when caused by metastatic disease
    • Alanine transaminase (ALT)/Aspartate transaminase (AST): ≤ 2.5 times the upper limit of the normal range (ULN) except when caused by metastatic disease
    • Urine protein creatinine (UPC) ratio < 1.0 at screening.

Exclusion Criteria

  1. Previous treatment with gemcitabine.
  2. History of Gastrointestinal Bleeding in the previous 3 months.
  3. Chemotherapy within 4 weeks prior to enrollment.
  4. Radiation therapy or evidence of acute effects of radiation therapy within 2 weeks prior to enrollment.
  5. Any major surgery within 4 weeks prior to enrollment.
  6. Presence of central nervous system or brain metastases.
  7. Urine protein: creatinine ratio ≥ 1.0 at screening.
  8. Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications).
  9. A prior history of hypertensive crisis or hypertensive encephalopathy.
  10. Peripheral neuropathy > grade I.
  11. Clinical AIDS or known positive HIV serology
  12. No concurrent clinically evident malignancy is allowed except inactive non-melanoma skin cancer and inactive cervical cancer diagnosed or other cancer for which the patient has been disease-free for five years.
  13. Unstable angina.
  14. New York Heart Association (NYHA) Grade II or greater congestive heart failure
  15. History of myocardial infarction within 6 months.
  16. History of stroke within 6 months.
  17. Clinically significant peripheral vascular disease.
  18. Evidence of bleeding diathesis or coagulopathy
  19. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment, anticipation of need for major surgical procedure during the course of the study.
  20. Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to enrollment.
  21. Pregnant (positive pregnancy test) or lactating.
  22. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to enrollment
  23. Serious, non-healing wound, ulcer, or bone fracture
  24. Inability to comply with study and/or follow-up procedures
  25. Participants with serious medical or psychiatric illness that would render chemotherapy unsafe are ineligible.
  26. Participants cannot have been in another experimental drug study other than a Bevacizumab cancer study within 4 weeks of the first infusion of these study medications.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00503906


Locations
United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Stefan Glück, MD, PhD University of Miami
  More Information

Publications:
Responsible Party: University of Miami
ClinicalTrials.gov Identifier: NCT00503906     History of Changes
Other Study ID Numbers: 20060913
SCCC-2006081 ( Other Identifier: University of Miami Sylvester Comprehensive Cancer Center )
First Submitted: July 17, 2007
First Posted: July 19, 2007
Results First Submitted: January 22, 2013
Results First Posted: April 2, 2013
Last Update Posted: May 12, 2017
Last Verified: May 2017

Keywords provided by University of Miami:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Bevacizumab
Albumin-Bound Paclitaxel
Paclitaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators