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Paclitaxel Albumin-Stabilized...

Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Gemcitabine, and Bevacizumab in Treating Patients With Metastatic Breast Cancer

Last Updated: 2017-04-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2013-08-31

Brief Summary

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RATIONALE: Drugs used in chemotherapy, such as gemcitabine and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine together with bevacizumab works in treating patients with metastatic breast cancer.

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Detailed Description

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OBJECTIVES:

Primary

* To determine the 6-month progression-free survival rate of patients with metastatic breast cancer treated with paclitaxel albumin-stabilized nanoparticle formulation, gemcitabine hydrochloride, and bevacizumab.

Secondary

* To determine the overall survival of patients treated with this regimen.
* To determine the progression-free survival of patients treated with this regimen.
* To determine the confirmed response rate in patients treated with this regimen.
* To determine the duration of response in patients treated with this regimen.
* To determine the time to treatment failure in patients treated with this regimen.
* To determine the quality of life of patients treated with this regimen.

OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and after every other course, and then after completion of treatment.

After completion of study treatment, patients are followed periodically for 5 years.

Conditions

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Breast Cancer

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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paclitaxel + gemcitabine + bevacizumab

Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and after every other course, and then after completion of treatment.

After completion of study treatment, patients are followed periodically for 5 years.

Group Type EXPERIMENTAL

bevacizumab

Intervention Type BIOLOGICAL

gemcitabine hydrochloride

Intervention Type DRUG

paclitaxel albumin-stabilized nanoparticle formulation

Intervention Type DRUG

Interventions

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bevacizumab

Intervention Type BIOLOGICAL

gemcitabine hydrochloride

Intervention Type DRUG

paclitaxel albumin-stabilized nanoparticle formulation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* No bleeding diathesis or uncontrolled coagulopathy
* No hemoptysis within the past 6 months
* No prior arterial or venous thrombosis within the past 12 months
* No history of cerebrovascular accident
* No history of hypertensive crisis or hypertensive encephalopathy
* No abdominal fistula or gastrointestinal perforation within the past 6 months
* No serious non-healing wound, ulcer, or fracture
* No clinically significant cardiac disease, defined as any of the following:

* Congestive heart failure
* Symptomatic coronary artery disease
* Unstable angina
* Cardiac arrhythmias not well controlled with medication
* Myocardial infarction within the past 12 months
* No comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for study entry or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior chemotherapy for metastatic disease

* May have received one prior adjuvant chemotherapy regimen
* Prior neoadjuvant chemotherapy allowed

* More than 6 months since prior adjuvant or neoadjuvant taxane (i.e., docetaxel or paclitaxel) therapy
* Prior hormonal therapy in either adjuvant or metastatic setting allowed
* More than 4 weeks since prior radiotherapy (except if to a non-target lesion only, or single dose radiation for palliation)

* Prior radiotherapy to a target lesion is allowed provided there has been clear progression of the lesion since radiotherapy was completed
* More than 4 weeks since prior cytotoxic chemotherapeutic agent or investigational drug
* More than 2 weeks since prior and no concurrent acetylsalicylic acid, anticoagulants, or thrombolytic agents (except for once-daily 81 mg acetylsalicylic acid)
* More than 6 weeks since prior major surgery, chemotherapy, or immunologic therapy
* More than 1 week since prior minor surgery (e.g., core biopsy)

* Placement of a vascular access device within 7 days is allowed
* More than 3 months since prior neurosurgery
* No concurrent treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered

* Trials related to symptom management (Cancer Control) which do not employ hormonal treatments or treatments that may block the path of the targeted agents used in this study may be allowed

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donald W. Northfelt, MD, FACP

Role: STUDY_CHAIR

Mayo Clinic

Locations

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Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Site Status

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, United States

Site Status

Reid Hospital & Health Care Services

Richmond, Indiana, United States

Site Status

Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, United States

Site Status

Mercy Regional Cancer Center at Mercy Medical Center

Cedar Rapids, Iowa, United States

Site Status