Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Gemcitabine, and Bevacizumab in Treating Patients With Metastatic Breast Cancer
Status: | Active, not recruiting |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | November 2008 |
Phase II Trial of Albumin-Bound Paclitaxel in Combination With Gemcitabine and Bevacizumab in Patients With Metastatic Breast Cancer
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.
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.
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 adverse event profile of this regimen.
- To determine the progression-free survival and overall survival of patients treated
with this regimen.
- To determine the confirmed response rate, duration of response, and 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.
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 adverse event profile of this regimen.
- To determine the progression-free survival and overall survival of patients treated
with this regimen.
- To determine the confirmed response rate, duration of response, and 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.
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed infiltrating breast cancer
- Clinical evidence of metastatic disease
- Measurable disease, defined as at least one measurable lesion per RECIST criteria
- No non-measurable disease only, defined as all other lesions, including small
lesions (longest diameter < 2 cm) and truly non-measurable lesions, including
any of the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Patients with HER-2/neu positive tumors, must have received prior treatment with
trastuzumab (Herceptin®) or have a contraindication for trastuzumab
- No evidence of active brain metastasis, including leptomeningeal involvement, on MRI
or CT scan
- CNS metastasis controlled by prior surgery and/or radiotherapy allowed
- Must be asymptomatic for ≥ 2 months with no evidence of progression prior
to study entry
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Life expectancy ≥ 12 weeks
- ECOG performance status 0-1
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9.0 g/dL
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Total bilirubin ≤ 1.5 times ULN
- Creatinine ≤ 1.5 mg/dL
- Urine protein:creatinine ratio < 1 or urinalysis < 1+ protein
- Patients discovered to have ≥ 1+ proteinuria at baseline must demonstrate
24-hour urine protein < 1 g
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 30 days after
completion of study therapy
- Able to complete questionnaires alone or with assistance
- No peripheral neuropathy > grade 1
- No history of allergy or hypersensitivity to albumin-bound paclitaxel, paclitaxel,
gemcitabine hydrochloride, bevacizumab, albumin, drug product excipients, or
chemically similar agents
- No stage III or IV invasive, non-breast malignancy within the past 5 years
- No other active malignancy, except nonmelanoma skin cancer or carcinoma in situ of
the cervix
- Patient must not be receiving other specific treatment for a prior malignancy
- No uncontrolled hypertension (i.e., blood pressure [BP] > 160/90 mm Hg on ≥ 2
occasions at least 5 minutes apart)
- Patients who have recently started or adjusted antihypertensive medications are
eligible providing that BP is < 140/90 mm Hg on any new regimen for ≥ 3
different observations in ≥ 14 days
- 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
We found this trial at
92
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
Allentown, Pennsylvania 18103
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19229 Mack Ave
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
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Ann Arbor, Michigan 48106
Ann Arbor, Michigan 48106
1.877.590.5995
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300 North Ave
Battle Creek, Michigan 49017
Battle Creek, Michigan 49017
(269) 245-8000
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720 E Rosser Ave
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Bismarck, North Dakota 58501
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701 10th St SE
Cedar Rapids, Iowa 52403
Cedar Rapids, Iowa 52403
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11850 Blackfoot St. NW
Suite 130
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
763-236-0808
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Grandview Hospital You'll feel like part of our family when you visit Grandview Medical Center...
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18101 Oakwood Blvd
Dearborn, Michigan 48124
Dearborn, Michigan 48124
(313) 593-8620
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300 East Locust St., Ste 350
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 244-7586
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1221 Pleasant St
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 241-4141
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1221 Pleasant St Suite 100
Des Moines, Iowa 50309
Des Moines, Iowa 50309
(515) 282-2921
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411 Laurel St New Visions
Des Moines, Iowa 50314
Des Moines, Iowa 50314
(515) 247-3970
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411 Laurel Street
Des Moines, Iowa 50314
Des Moines, Iowa 50314
(515) 247-3121
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Miller - Dwan Medical Center Essentia Health-Duluth, located in the Miller-Dwan building, is a 165-bed...
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Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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Blanchard Valley Medical Associates Blanchard Valley Medical Associates was founded in 1974 by Dr. William...
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550 Osborne Road
Fridley, Minnesota 55432
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763-236-5000
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250 Cherry St SE
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
(616) 685-5225
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1101 26th Street South
Great Falls, Montana 59405
Great Falls, Montana 59405
406.455.5000
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114 Woodland St, Hartford
Hartford, Connecticut 06105
Hartford, Connecticut 06105
(860) 714-4000
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1575 Beam Avenue
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
651-232-7970
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1000 4th St SW
Mason City, Iowa 50401
Mason City, Iowa 50401
(641) 428-7000
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800 E 28th St
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
612-863-4000
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701 Park Ave
Minneapolis, Minnesota 55415
Minneapolis, Minnesota 55415
(612) 873-3000
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7500 Mercy Rd
Omaha, Nebraska 68124
Omaha, Nebraska 68124
(402) 398-6060
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1001 PENNSYLVANIA AVENUE
Ottumwa, Iowa 52501
Ottumwa, Iowa 52501
641.684.2300
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St. Joseph Mercy Oakland St. Joseph Mercy Oakland (SJMO) is a 443-bed comprehensive, community and...
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2601 Electric Ave
Port Huron, Michigan 48060
Port Huron, Michigan 48060
(810) 985-1500
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Mercy Regional Cancer Center at Mercy Hospital The Mercy Regional Cancer Center at St. Joseph...
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Reid Hospital & Health Care Services As you will see on campus and throughout our...
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Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
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800 S Washington Ave
Saginaw, Michigan 48601
Saginaw, Michigan 48601
(989) 907-8115
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Seton Cancer Institute at Saint Mary's - Saginaw At St. Mary's of Michigan, we continue...
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CentraCare Clinic - River Campus CentraCare Health is a not-for-profit health care system that provides...
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Coborn Cancer Center CentraCare Health is a not-for-profit health care system that provides comprehensive, high-quality...
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Park Nicollet Cancer Center Park Nicollet Methodist Hospital has a long and rich history in...
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United Hospital United Hospital is the largest hospital in the Twin Cities east metro area,...
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Mayo Clinic Scottsdale Mayo Clinic Arizona was the second Mayo practice to be established outside...
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1455 St. Francis Ave.
Shakopee, Minnesota 55379
Shakopee, Minnesota 55379
952.428.2031
![St. Francis Cancer Center at St. Francis Medical Center](/wp-content/uploads/logos/st-francis-cancer-center-at-st-francis-medical-center.jpg)
St. Francis Cancer Center at St. Francis Medical Center A collaboration of St. Francis Regional...
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Siouxland Hematology-Oncology Associates, LLP Siouxland Hematology-Oncology Associates (SHOA) provides medical oncology treatment. In addition to...
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Mercy Medical Center - Sioux City Living the traditions, visions and values of the Sisters...
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St. Luke's Regional Medical Center St. Luke's is a patient and family-centered hospital that delivering...
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Regions Hospital Cancer Care Center Established in 1872, Regions Hospital is a private, not-for-profit organization....
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Munson Medical Center There’s no place quite like northern Michigan, and there is no other...
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3130 N. County Rd. 25-A
Troy, Ohio 45373
Troy, Ohio 45373
(937) 440-4000
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UVMC Cancer Care Center at Upper Valley Medical Center Upper Valley Medical Center (UVMC) is...
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Ridgeview Medical Center Ridgeview Medical Center is an independent, nonprofit, regional health care system located...
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301 Becker Ave SW
Willmar, Minnesota 56201
Willmar, Minnesota 56201
(320) 231-4570
![Willmar Cancer Center at Rice Memorial Hospital](/wp-content/uploads/logos/willmar-cancer-center-at-rice-memorial-hospital.jpg)
Willmar Cancer Center at Rice Memorial Hospital As a Community Hospital Cancer Program approved by...
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Metro Health Hospital Metro Health is an integrated healthcare system offering expert, award-winning care that
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1141 N Monroe Dr
Xenia, Ohio 45385
Xenia, Ohio 45385
937-352-2005
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Ruth G. McMillan Cancer Center at Greene Memorial Hospital For more than 60 years, Greene...
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