ABI-007 (Nab-Paclitaxel) and Gemcitabine in Treating Women With Metastatic Breast Cancer
NCT ID: NCT00110084
Last Updated: 2011-06-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2005-08-31
2010-08-31
Brief Summary
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PURPOSE: This phase II trial is studying how well giving ABI-007 together with gemcitabine works in treating women with metastatic breast cancer.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nab-paclitaxel/Gemcitabine
Gemcitabine
1000 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle
Paclitaxel protein-bound particles for injectable suspension (albumin-bound)
125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle
Interventions
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Gemcitabine
1000 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle
Paclitaxel protein-bound particles for injectable suspension (albumin-bound)
125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Mayo Clinic Cancer Center
Principal Investigators
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Vivek Roy, MD, FACP
Role: STUDY_CHAIR
Mayo Clinic
Philip J. Stella, MD
Role: STUDY_CHAIR
CCOP - Michigan Cancer Research Consortium
Tom R. Fitch, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Timothy J. Hobday, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mobile Infirmary Medical Center
Mobile, Alabama, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Aurora Presbyterian Hospital
Aurora, Colorado, United States
Boulder Community Hospital
Boulder, Colorado, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States
Porter Adventist Hospital
Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States
St. Joseph Hospital
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Sky Ridge Medical Center
Lone Tree, Colorado, United States
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States
St. Mary-Corwin Regional Medical Center
Pueblo, Colorado, United States
North Suburban Medical Center
Thorton, Colorado, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Piedmont Hospital
Atlanta, Georgia, United States
Northside Hospital Cancer Center
Atlanta, Georgia, United States
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
WellStar Cobb Hospital
Austell, Georgia, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia, United States
Gwinnett Medical Center
Lawrenceville, Georgia, United States
Kennestone Cancer Center at Wellstar Kennestone Hospital
Marietta, Georgia, United States
Southern Regional Medical Center
Riverdale, Georgia, United States
Cancer Research Center of Hawaii
Honolula, Hawaii, United States
OnCare Hawaii, Incorporated - Lusitana
Honolulu, Hawaii, United States
Queen's Cancer Institute at Queen's Medical Center
Honolulu, Hawaii, United States
Straub Clinic and Hospital, Incorporated
Honolulu, Hawaii, United States
OnCare Hawaii, Incorporated - Kuakini
Honolulu, Hawaii, United States
St. Francis Medical Center
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Kapiolani Medical Center at Pali Momi
‘Aiea, Hawaii, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, United States
St. Joseph Medical Center
Bloomington, Illinois, United States
Graham Hospital
Canton, Illinois, United States
Memorial Hospital
Carthage, Illinois, United States
Eureka Community Hospital
Eureka, Illinois, United States
Galesburg Clinic
Galesburg, Illinois, United States
Galesburg Cottage Hospital
Galesburg, Illinois, United States
Mason District Hospital
Havana, Illinois, United States
Hopedale Medical Complex
Hopedale, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States
Kewanee Hospital
Kewanee, Illinois, United States
McDonough District Hospital
Macomb, Illinois, United States
Trinity Medical Center - East
Moline, Illinois, United States
Moline, Illinois, United States
BroMenn Regional Medical Center
Normal, Illinois, United States
Community Cancer Center
Normal, Illinois, United States
Community Hospital of Ottawa
Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States
Proctor Hospital
Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
OSF St. Francis Medical Center
Peoria, Illinois, United States
Illinois Valley Community Hospital
Peru, Illinois, United States
Perry Memorial Hospital
Princeton, Illinois, United States
St. Margaret's Hospital
Spring Valley, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States
McFarland Clinic, P. C.
Ames, Iowa, United States
Bettendorf, Iowa, United States
St. Luke's Hospital
Cedar Rapids, Iowa, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States
Mercy Capitol Hospital
Des Moines, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, United States
Ottumwa Regional Health Center Cancer Center
Ottumwa, Iowa, United States
Siouxland Hematology-Oncology Associates
Sioux City, Iowa, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, United States
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines, Iowa, United States
Cancer Center of Kansas, P.A. - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas, P.A. - El Dorado
El Dorado, Kansas, United States
Cancer Center of Kansas, P.A. - Kingman
Kingman, Kansas, United States
Southwest Medical Center
Liberal, Kansas, United States
Cancer Center of Kansas, P.A. - Newton
Newton, Kansas, United States
Cancer Center of Kansas, P.A. - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas, P.A. - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas, P.A. - Salina
Salina, Kansas, United States
Cancer Center of Kansas, P.A. - Wellington
Wellington, Kansas, United States
Associates in Womens Health, P.A. - North Review
Wichita, Kansas, United States
Cancer Center of Kansas, P.A. - Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas, P.A. - Wichita
Wichita, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Cancer Center of Kansas, P.A. - Winfield
Winfield, Kansas, United States
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States
Green Bay Oncology, Limited - Iron Mountain
Iron Mountain, Michigan, United States
Haematology-Oncology Associates of Ohio and Michigan, P.C.
Lambertville, Michigan, United States
Community Cancer Center of Monroe
Monroe, Michigan, United States
Mercy Memorial Hospital System
Monroe, Michigan, United States
Seton Cancer Institute - Saginaw
Saginaw, Michigan, United States
St. John Macomb Hospital
Warren, Michigan, United States
Alexandria, Minnesota, United States
MeritCare Clinic - Bemidji
Bemidji, Minnesota, United States
Brainerd Medical Center
Brainerd, Minnesota, United States
St. Joseph's Medical Center
Brainerd, Minnesota, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States
CCOP - Duluth
Duluth, Minnesota, United States
Miller-Dwan Medical Center
Duluth, Minnesota, United States
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Fergus Falls, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, United States
Meeker County Memorial Hospital
Lichfield, Minnesota, United States
Immanuel St. Joseph's Clinic
Mankato, Minnesota, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States
Chippewa County - Montevideo Hospital
Montevideo, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, United States
Coborn Cancer Center
Saint Cloud, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
Park Nicollet Health Services
Saint Louis Park, Minnesota, United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, United States
St. Joseph's Hospital
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Saint Francis Cancer Center
Shakopee, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Woodwinds Health Campus
Woodbury, Minnesota, United States
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Rutherford Hospital
Rutherfordton, North Carolina, United States
Bismarck Cancer Center
Bismarck, North Dakota, United States
Cancer Care Center at Medcenter One Hospital
Bismarck, North Dakota, United States
Mid Dakota Clinic, P. C.
Bismarck, North Dakota, United States
St. Alexius Medical Center
Bismarck, North Dakota, United States
CCOP - MeritCare Hospital
Fargo, North Dakota, United States
MeritCare Medical Group
Fargo, North Dakota, United States
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, United States
Wood County Oncology Center
Bowling Green, Ohio, United States
Grandview Hospital
Dayton, Ohio, United States
Good Samaritan Hospital
Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States
Samaritan North Cancer Care Center
Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States
CCOP - Dayton
Dayton, Ohio, United States
Blanchard Valley Medical Associates
Findlay, Ohio, United States
Fremont Memorial Hospital
Fremont, Ohio, United States
Kenton Oncology, Incorporated
Kenton, Ohio, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States
Lima Memorial Hospital
Lima, Ohio, United States
Northwest Ohio Oncology Center
Maumee, Ohio, United States
St. Luke's Hospital
Maumee, Ohio, United States
Middletown Regional Hospital
Middletown, Ohio, United States
St. Charles Mercy Hospital
Oregon, Ohio, United States
Toledo Clinic - Oregon
Oregon, Ohio, United States
Firelands Regional Medical Center
Sandusky, Ohio, United States
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States
Promedica Cancer Center at Flower Hospital
Sylvania, Ohio, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, United States
Toledo Hospital
Toledo, Ohio, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, United States
Medical University of Ohio Cancer Center
Toledo, Ohio, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States
Toledo Surgical Specialists
Toledo, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States
Fulton County Health Center
Wauseon, Ohio, United States
United States Air Force Medical Center Wright-Patterson
Wright-Patterson AFB, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Geisinger Medical Group
State College, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
Rose Ramer Cancer Clinic at Anderson Area Medical Center
Anderson, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Countries
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References
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Roy V, LaPlant BR, Gross GG, Bane CL, Palmieri FM; North Central Cancer Treatment Group. Phase II trial of weekly nab (nanoparticle albumin-bound)-paclitaxel (nab-paclitaxel) (Abraxane) in combination with gemcitabine in patients with metastatic breast cancer (N0531). Ann Oncol. 2009 Mar;20(3):449-53. doi: 10.1093/annonc/mdn661. Epub 2008 Dec 15.
Roy V, LaPlant BR, Gross GG, et al.: NCCTG phase II trial N0531of weekly nab-paclitaxel (nab-p) in combination with gemcitabine (gem) in patients with metastatic breast cancer (MBC). [Abstract] J Clin Oncol 25 (Suppl 18): A-1048, 2007.
Moreno-Aspitia A, Perez EA. North Central Cancer Treatment Group N0531: Phase II Trial of weekly albumin-bound paclitaxel (ABI-007; Abraxane) in combination with gemcitabine in patients with metastatic breast cancer. Clin Breast Cancer. 2005 Oct;6(4):361-4. doi: 10.3816/CBC.2005.n.042. No abstract available.
Other Identifiers
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N0531
Identifier Type: OTHER
Identifier Source: secondary_id
855-05
Identifier Type: OTHER
Identifier Source: secondary_id
N0433
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000423195
Identifier Type: -
Identifier Source: org_study_id
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