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Phase II Trial of Weekly Nab (Nanoparticle Albumin Bound)-Paclitaxel (Nab-paclitaxel) (Abraxane®) in Combination With Gemcitabine in Patients With Metastatic Breast Cancer


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

Thank you

Trial Information

Phase II Trial of Weekly Nab (Nanoparticle Albumin Bound)-Paclitaxel (Nab-paclitaxel) (Abraxane®) in Combination With Gemcitabine in Patients With Metastatic Breast Cancer


OBJECTIVES:

Primary

- Determine the antitumor activity of ABI-007 and gemcitabine, in terms of response rate
in women with metastatic breast cancer.

- Determine the toxicity profile of this regimen, in terms of incidence and severity of
observed toxic effects, in these patients.

Secondary

* Determine the time to disease progression and survival of patients treated with this
regimen.

OUTLINE: This is a multicenter study. Patients receive ABI-007 IV over 30 minutes and
gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence
of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for up to 5 years.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study within 20 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed invasive breast cancer

- Clinical evidence of metastatic disease

+ No bone metastases or other non-measurable disease as the only evidence of
metastasis

- Measurable disease, defined as at least 1 measurable lesion

- The following are considered non-measurable disease:

- Small lesions (< 2 cm)

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural or pericardial effusions

- Inflammatory breast disease

- Lymphangitis cutis or pulmonis

- Abdominal masses that are not confirmed and followed by imaging techniques

- Cystic lesions

- HER2(human epidermal growth factor receptor 2)-positive disease allowed provided
patient has received prior treatment with trastuzumab

- No evidence of active brain metastasis, including leptomeningeal involvement

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age

- 18 and over Sex

- Female Menopausal status

- Not specified Performance status

- ECOG 0-1 Life expectancy

- At least 12 weeks Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL Hepatic

- AST and ALT ≤ 2.5 times upper limit of normal (ULN)

- Bilirubin ≤ 1.5 times ULN Renal

- Creatinine ≤ 1.5 mg/dL Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 30 days after
completion of study treatment

- No pre-existing peripheral neuropathy > grade 1

- No other clinically significant illness or significant medical condition that would
preclude study participation

- No history of allergy or hypersensitivity to paclitaxel protein-bound particles in an
injectable suspension, paclitaxel, gemcitabine, albumin, drug product excipients, or
agents that are chemically similar to study drugs

- No serious medical risk factors involving any of the major organ systems that would
preclude study participation

- No active stage III or IV invasive non-breast malignancy within the past 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics Chemotherapy

- No more than 1 prior adjuvant chemotherapy regimen

- No prior chemotherapy for metastatic disease

- At least 6 months since prior adjuvant or neoadjuvant taxane

- More than 2 weeks since prior cytotoxic chemotherapy

- Prior neoadjuvant chemotherapy allowed

- No other concurrent chemotherapy Endocrine therapy

- Prior hormonal treatment as adjuvant therapy or for metastatic disease allowed
Radiotherapy

- Prior radiotherapy to target lesion allowed provided there is evidence of disease
progression after completion of treatment

- More than 2 weeks since prior radiotherapy, except radiotherapy to a non-target
lesion only or single-dose palliative radiotherapy

- No concurrent radiotherapy Surgery

- Not specified Other

- More than 2 weeks since prior investigational drugs

- No concurrent participation in another clinical trial that is studying
investigational procedures or therapies

- Concurrent bisphosphonates (e.g., pamidronate or zoledronate) allowed for palliation
of pain or lytic lesions from breast cancer

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of Patients With Confirmed Responses

Outcome Description:

Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart. Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.

Outcome Time Frame:

Two consecutive evaluations at least 6 weeks apart

Safety Issue:

No

Principal Investigator

Vivek Roy, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000423195

NCT ID:

NCT00110084

Start Date:

August 2005

Completion Date:

August 2010

Related Keywords:

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

Name

Location

Mayo ClinicRochester, Minnesota  55905
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Aurora Presbyterian HospitalAurora, Colorado  80012
Boulder Community HospitalBoulder, Colorado  80301-9019
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
Porter Adventist HospitalDenver, Colorado  80210
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
St. Joseph HospitalDenver, Colorado  80218
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
Sky Ridge Medical CenterLone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United HospitalLongmont, Colorado  80502
North Suburban Medical CenterThornton, Colorado  80229
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Seton Cancer Institute - SaginawSaginaw, Michigan  48601
St. John Macomb HospitalWarren, Michigan  48093
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
CCOP - DuluthDuluth, Minnesota  55805
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
CCOP - MeritCare HospitalFargo, North Dakota  58122
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Rapid City Regional HospitalRapid City, South Dakota  57709
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
Hinsdale, Illinois  60521
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
St. Vincent Mercy Medical CenterToledo, Ohio  43608
CCOP - Colorado Cancer Research Program, IncorporatedDenver, Colorado  80224
Northside Hospital Cancer CenterAtlanta, Georgia  30342-1611
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Toledo HospitalToledo, Ohio  43606
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
St. Mary's - Duluth Clinic Cancer CenterDuluth, Minnesota  55805
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Siouxland Hematology-Oncology AssociatesSioux City, Iowa  51101
Siouxland Regional Cancer CenterSioux City, Iowa  51101-1733
Cancer Center of Kansas, P.A. - El DoradoEl Dorado, Kansas  67042
Southwest Medical CenterLiberal, Kansas  67901
Cancer Center of Kansas, P.A. - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, P.A. - WichitaWichita, Kansas  67214
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
St. Mary-Corwin Regional Medical CenterPueblo, Colorado  81004
Saint Joseph's Hospital of AtlantaAtlanta, Georgia  30342-1701
Piedmont HospitalAtlanta, Georgia  30309
WellStar Cobb HospitalAustell, Georgia  30106
Charles B. Eberhart Cancer Center at DeKalb Medical CenterDecatur, Georgia  30033
Gwinnett Medical CenterLawrenceville, Georgia  30045
Kennestone Cancer Center at Wellstar Kennestone HospitalMarietta, Georgia  30060
Southern Regional Medical CenterRiverdale, Georgia  30274-2600
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
Trinity Medical Center - EastMoline, Illinois  61265
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
McFarland Clinic, P. C.Ames, Iowa  50010
Bettendorf, Iowa  52722
St. Luke's HospitalCedar Rapids, Iowa  52402
Mercy Regional Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
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
Cancer Center of Kansas, P.A. - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas, P.A. - KingmanKingman, Kansas  67068
Cancer Center of Kansas, P.A. - NewtonNewton, Kansas  67114
Cancer Center of Kansas, P.A. - PrattPratt, Kansas  67124
Cancer Center of Kansas, P.A. - SalinaSalina, Kansas  67042
Cancer Center of Kansas, P.A. - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, P.A. - Medical Arts TowerWichita, Kansas  67208
Associates in Womens Health, P.A. - North ReviewWichita, Kansas  67203
Cancer Center of Kansas, P.A. - WinfieldWinfield, Kansas  67156
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
St. Joseph Mercy Cancer Center at St. Joseph Mercy HospitalAnn Arbor, Michigan  48106-0995
Green Bay Oncology, Limited - Iron MountainIron Mountain, Michigan  49801
Haematology-Oncology Associates of Ohio and Michigan, P.C.Lambertville, Michigan  48144
Community Cancer Center of MonroeMonroe, Michigan  48162
Mercy Memorial Hospital SystemMonroe, Michigan  48162
Alexandria, Minnesota  56308
MeritCare Clinic - BemidjiBemidji, Minnesota  56601
Brainerd Medical CenterBrainerd, Minnesota  56401
St. Joseph's Medical CenterBrainerd, Minnesota  56401
Virginia Piper Cancer Institute at Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Chippewa County - Montevideo HospitalMontevideo, Minnesota  56265
Hubert H. Humphrey Cancer Center at North Memorial Medical CenterRobbinsdale, Minnesota  55422-2900
Coborn Cancer CenterSaint Cloud, Minnesota  56303
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Park Nicollet Health ServicesSt. Louis Park, Minnesota  55416
Cancer Care Center at Medcenter One HospitalBismarck, North Dakota  58501
Bismarck Cancer CenterBismarck, North Dakota  58501
St. Alexius Medical CenterBismarck, North Dakota  58502
Mid Dakota Clinic, P. C.Bismarck, North Dakota  58501
MeritCare Medical GroupFargo, North Dakota  58122
Wood County Oncology CenterBowling Green, Ohio  43402
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
Fremont Memorial HospitalFremont, Ohio  43420
Kenton Oncology, IncorporatedKenton, Ohio  43326
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Lima Memorial HospitalLima, Ohio  45804
St. Luke's HospitalMaumee, Ohio  43537
Northwest Ohio Oncology CenterMaumee, Ohio  43537
Middletown Regional HospitalMiddletown, Ohio  45044
Toledo Clinic - OregonOregon, Ohio  43616
St. Charles Mercy HospitalOregon, Ohio  43616
North Coast Cancer Care, IncorporatedSandusky, Ohio  44870
Firelands Regional Medical CenterSandusky, Ohio  44870
Promedica Cancer Center at Flower HospitalSylvania, Ohio  43560
Mercy Hospital of TiffinTiffin, Ohio  44883
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
Toledo Surgical SpecialistsToledo, Ohio  43623
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Fulton County Health CenterWauseon, Ohio  43567
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Green Bay Oncology, Limited at St. Vincent HospitalGreen Bay, Wisconsin  54301-3526
Rose Ramer Cancer Clinic at Anderson Area Medical CenterAnderson, South Carolina  29621
Miller-Dwan Medical CenterDuluth, Minnesota  55805
Geisinger Medical GroupState College, Pennsylvania  16801
Mercy Cancer Center at Mercy Medical Center - North IowaMason City, Iowa  50401
Saint Francis Cancer CenterShakopee, Minnesota  55379
St. Joseph's HospitalSt Paul, Minnesota  55102
Cancer Resource Center - LincolnLincoln, Nebraska  68510
Altru Cancer Center at Altru HospitalGrand Forks, North Dakota  58201
St. Francis Medical CenterHonolulu, Hawaii  96817
Queen's Cancer Institute at Queen's Medical CenterHonolulu, Hawaii  96813
Immanuel St. Joseph's ClinicMankato, Minnesota  56002
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Mayo Clinic in ArizonaScottsdale, Arizona  85259-5404
Mayo Clinic in FloridaJacksonville, Florida  32224
Woodwinds Health CampusWoodbury, Minnesota  55125
Kapiolani Medical Center at Pali MomiAiea, Hawaii  96701
Kapiolani Medical Center for Women and ChildrenHonolulu, Hawaii  96826
Straub Clinic and Hospital, IncorporatedHonolulu, Hawaii  96813
OnCare Hawaii, Incorporated - KuakiniHonolulu, Hawaii  96817
OnCare Hawaii, Incorporated - LusitanaHonolulu, Hawaii  96813
United States Air Force Medical Center Wright-PattersonWright-Patterson Afb, Ohio  45433-5529
Ottumwa Regional Health Center Cancer CenterOttumwa, Iowa  52501