ABI-007 (Nab-Paclitaxel) and Gemcitabine in Treating Women With Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00110084
- Lead Sponsor
- Mayo Clinic
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as ABI-007(Nab-Paclitaxel((Nanoparticle Albumin Bound)-Paclitaxel)) and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving ABI-007 together with gemcitabine works in treating women with metastatic breast cancer.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nab-paclitaxel/Gemcitabine Paclitaxel protein-bound particles for injectable suspension (albumin-bound) - Nab-paclitaxel/Gemcitabine Gemcitabine -
- Primary Outcome Measures
Name Time Method Proportion of Patients With Confirmed Responses Two consecutive evaluations at least 6 weeks apart 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.
- Secondary Outcome Measures
Name Time Method Progression-free Survival Time from registration to progression or death (up to 5 years) Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who are alive and progression free being censored on the date of their last evaluation.
Overall Survival Death or last follow-up (up to 5 years) Overall survival time was defined as the number of days from registration to the date of death or last follow-up
Adverse Event Every 6 weeks Number of patients that experienced adverse events (grade 3 or more occurring in \>5% of patients) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0
Trial Locations
- Locations (196)
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
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
Bismarck Cancer Center
🇺🇸Bismarck, North Dakota, United States
St. Alexius Medical Center
🇺🇸Bismarck, North Dakota, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
Northwest Ohio Oncology Center
🇺🇸Maumee, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Geisinger Medical Group
🇺🇸State College, Pennsylvania, United States
Rose Ramer Cancer Clinic at Anderson Area Medical Center
🇺🇸Anderson, South Carolina, 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
Swedish Medical Center
🇺🇸Englewood, Colorado, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
Trinity Medical Center - East
🇺🇸Moline, Illinois, United States
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Kapiolani Medical Center at Pali Momi
🇺🇸Aiea, Hawaii, United States
Hope Cancer Care Center at Longmont United Hospital
🇺🇸Longmont, Colorado, United States
Saint Joseph's Hospital of Atlanta
🇺🇸Atlanta, Georgia, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Penrose Cancer Center at Penrose Hospital
🇺🇸Colorado Springs, Colorado, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
Gwinnett Medical Center
🇺🇸Lawrenceville, Georgia, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center
🇺🇸Decatur, Georgia, United States
Cancer Center of Kansas, P.A. - Pratt
🇺🇸Pratt, Kansas, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Hickman Cancer Center at Bixby Medical Center
🇺🇸Adrian, Michigan, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Community Hospital of Ottawa
🇺🇸Ottawa, 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
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
WellStar Cobb Hospital
🇺🇸Austell, Georgia, United States
St. Mary-Corwin Regional Medical Center
🇺🇸Pueblo, Colorado, United States
Northside Hospital Cancer Center
🇺🇸Atlanta, Georgia, United States
Southern Regional Medical Center
🇺🇸Riverdale, Georgia, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
St. Luke's Hospital
🇺🇸Maumee, Ohio, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Siouxland Hematology-Oncology Associates
🇺🇸Sioux City, Iowa, United States
McFarland Clinic, P. C.
🇺🇸Ames, Iowa, United States
Cancer Center of Kansas, P.A. - Chanute
🇺🇸Chanute, Kansas, United States
Ottumwa Regional Health Center Cancer Center
🇺🇸Ottumwa, Iowa, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Siouxland Regional Cancer Center
🇺🇸Sioux City, Iowa, United States
Cancer Center of Kansas, P.A. - Newton
🇺🇸Newton, Kansas, United States
Mercy and Unity Cancer Center at Unity Hospital
🇺🇸Fridley, Minnesota, 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
Haematology-Oncology Associates of Ohio and Michigan, P.C.
🇺🇸Lambertville, Michigan, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Fremont Memorial Hospital
🇺🇸Fremont, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic
🇺🇸Toledo, Ohio, United States
Mercy Hospital of Tiffin
🇺🇸Tiffin, Ohio, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Cancer Center of Kansas, P.A. - Parsons
🇺🇸Parsons, Kansas, United States
Green Bay Oncology, Limited at St. Mary's Hospital
🇺🇸Green Bay, Wisconsin, United States
Cancer Center of Kansas, P.A. - Winfield
🇺🇸Winfield, Kansas, United States
Green Bay Oncology, Limited - Sturgeon Bay
🇺🇸Sturgeon Bay, Wisconsin, United States
Mercy and Unity Cancer Center at Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Coborn Cancer Center
🇺🇸Saint Cloud, Minnesota, United States
Hennepin County Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
🇺🇸Robbinsdale, Minnesota, United States
Mid Dakota Clinic, P. C.
🇺🇸Bismarck, North Dakota, United States
MeritCare Medical Group
🇺🇸Fargo, North Dakota, United States
Lima Memorial Hospital
🇺🇸Lima, Ohio, United States
Toledo Clinic - Oregon
🇺🇸Oregon, Ohio, United States
North Coast Cancer Care, Incorporated
🇺🇸Sandusky, Ohio, United States
Chippewa County - Montevideo Hospital
🇺🇸Montevideo, Minnesota, United States
Wood County Oncology Center
🇺🇸Bowling Green, Ohio, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
CentraCare Clinic - River Campus
🇺🇸St. Cloud, Minnesota, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
St. Mary's - Duluth Clinic Cancer Center
🇺🇸Duluth, Minnesota, United States
Toledo Surgical Specialists
🇺🇸Toledo, Ohio, United States
HealthEast Cancer Care at St. John's Hospital
🇺🇸Maplewood, Minnesota, United States
Medical University of Ohio Cancer Center
🇺🇸Toledo, Ohio, United States
Fulton County Health Center
🇺🇸Wauseon, Ohio, United States
Woodwinds Health Campus
🇺🇸Woodbury, Minnesota, United States
Firelands Regional Medical Center
🇺🇸Sandusky, Ohio, United States
Cancer Resource Center - Lincoln
🇺🇸Lincoln, Nebraska, United States
Cancer Care Center at Medcenter One Hospital
🇺🇸Bismarck, North Dakota, United States
Altru Cancer Center at Altru Hospital
🇺🇸Grand Forks, North Dakota, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Park Nicollet Health Services
🇺🇸St. Louis Park, Minnesota, United States
United Hospital
🇺🇸St. Paul, Minnesota, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
Kenton Oncology, Incorporated
🇺🇸Kenton, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Middletown Regional Hospital
🇺🇸Middletown, Ohio, 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
Toledo Hospital
🇺🇸Toledo, Ohio, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Promedica Cancer Center at Flower Hospital
🇺🇸Sylvania, Ohio, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
United States Air Force Medical Center Wright-Patterson
🇺🇸Wright-Patterson Afb, Ohio, United States
Medical X-Ray Center, PC
🇺🇸Sioux Falls, South Dakota, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Sioux Valley Hospital and University of South Dakota Medical Center
🇺🇸Sioux Falls, South Dakota, United States
St. Mary's Hospital Medical Center - Green Bay
🇺🇸Green Bay, Wisconsin, United States
Porter Adventist Hospital
🇺🇸Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center
🇺🇸Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Incorporated
🇺🇸Denver, Colorado, United States
St. Joseph Hospital
🇺🇸Denver, Colorado, United States
Rose Medical Center
🇺🇸Denver, Colorado, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, P.A. - Wellington
🇺🇸Wellington, Kansas, United States
North Suburban Medical Center
🇺🇸Thorton, Colorado, United States
St. Joseph's Hospital
🇺🇸St Paul, Minnesota, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
🇺🇸Ottawa, Illinois, United States
Boulder Community Hospital
🇺🇸Boulder, Colorado, United States
Sky Ridge Medical Center
🇺🇸Lone Tree, Colorado, United States
Kennestone Cancer Center at Wellstar Kennestone Hospital
🇺🇸Marietta, Georgia, United States
Mayo Clinic in Florida
🇺🇸Jacksonville, Florida, United States
Cancer Research Center of Hawaii
🇺🇸Honolula, Hawaii, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Kewanee Hospital
🇺🇸Kewanee, Illinois, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
🇺🇸Peoria, Illinois, United States
Cedar Rapids Oncology Associates
🇺🇸Cedar Rapids, Iowa, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Mercy Regional Cancer Center at Mercy Medical Center
🇺🇸Cedar Rapids, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
🇺🇸Mason City, Iowa, United States
Medical Oncology and Hematology Associates - West Des Moines
🇺🇸West Des Moines, Iowa, United States
Cancer Center of Kansas, P.A. - Kingman
🇺🇸Kingman, Kansas, United States
Associates in Womens Health, P.A. - North Review
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, P.A. - Salina
🇺🇸Salina, 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
Seton Cancer Institute - Saginaw
🇺🇸Saginaw, Michigan, United States
Community Cancer Center of Monroe
🇺🇸Monroe, Michigan, United States
Mercy Memorial Hospital System
🇺🇸Monroe, Michigan, United States
Green Bay Oncology, Limited - Iron Mountain
🇺🇸Iron Mountain, Michigan, United States
Green Bay Oncology, Limited - Escanaba
🇺🇸Escanaba, Michigan, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Immanuel St. Joseph's Clinic
🇺🇸Mankato, Minnesota, United States
MeritCare Clinic - Bemidji
🇺🇸Bemidji, Minnesota, United States
Hutchinson Area Health Care
🇺🇸Hutchinson, Minnesota, United States
Meeker County Memorial Hospital
🇺🇸Lichfield, Minnesota, United States
Brainerd Medical Center
🇺🇸Brainerd, Minnesota, United States
St. Joseph's Medical Center
🇺🇸Brainerd, Minnesota, United States
Miller-Dwan Medical Center
🇺🇸Duluth, Minnesota, United States
Saint Francis Cancer Center
🇺🇸Shakopee, Minnesota, United States
Regions Hospital Cancer Care Center
🇺🇸St. Paul, Minnesota, United States
CCOP - MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
St. Charles Mercy Hospital
🇺🇸Oregon, Ohio, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
🇺🇸Allentown, Pennsylvania, United States
Green Bay Oncology, Limited at St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Aurora Presbyterian Hospital
🇺🇸Aurora, Colorado, 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
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
John Stoddard Cancer Center at Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States
Mercy Capitol Hospital
🇺🇸Des Moines, Iowa, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard 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 Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
🇺🇸Des Moines, Iowa, United States