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Phase II Trial of Albumin-Bound Paclitaxel in Combination With Gemcitabine and Bevacizumab in Patients With Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

Phase II Trial of Albumin-Bound Paclitaxel in Combination With Gemcitabine and Bevacizumab in 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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

6-month progression-free survival (PFS) rate

Safety Issue:

No

Principal Investigator

Donald W. Northfelt, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000593581

NCT ID:

NCT00662129

Start Date:

November 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • male breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Hurley Medical CenterFlint, Michigan  48503
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Duluth Clinic Cancer Center - DuluthDuluth, Minnesota  55805-1983
CCOP - DuluthDuluth, Minnesota  55805
Miller - Dwan Medical CenterDuluth, Minnesota  55805
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
CCOP - DaytonKettering, Ohio  45429
CCOP - Grand RapidsGrand Rapids, Michigan  49503
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
McCreery Cancer Center at Ottumwa RegionalOttumwa, Iowa  52501
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Munson Medical CenterTraverse City, Michigan  49684
Big Sky OncologyGreat Falls, Montana  59405
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Mercy Regional Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Mecosta County Medical CenterBig Rapids, Michigan  49307
Alexandria, Minnesota  56308
Coborn Cancer CenterSaint Cloud, Minnesota  56303
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Immanuel Medical CenterOmaha, Nebraska  68122
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Bismarck Cancer CenterBismarck, North Dakota  58501
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Mercy Cancer Center at Mercy Medical Center - North IowaMason City, Iowa  50401
Cancer Resource Center - LincolnLincoln, Nebraska  68510
Reid Hospital & Health Care ServicesRichmond, Indiana  47374
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Willmar Cancer Center at Rice Memorial HospitalWillmar, Minnesota  56201
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Alegant Health Cancer Center at Bergan Mercy Medical CenterOmaha, Nebraska  68124
Wayne HospitalGreenville, Ohio  45331
Clinton Memorial HospitalWilmington, Ohio  45177
Mid Dakota Clinic, PCBismarck, North Dakota  58501
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Metro Health HospitalGrand Rapids, Michigan  49506
Mercy General Health PartnersMuskegon, Michigan  49443
Medcenter One Hospital Cancer Care CenterBismarck, North Dakota  58501
St. Alexius Medical Center Cancer CenterBismarck, North Dakota  58502