Irinotecan and Docetaxel in Treating Patients With Refractory Metastatic Breast Cancer
- Registration Number
- NCT00079118
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving irinotecan together with docetaxel works in treating patients with refractory metastatic breast cancer.
- Detailed Description
OBJECTIVES:
Primary
* Determine the antitumor activity of irinotecan and docetaxel, in terms of response rate, in patients with refractory metastatic breast cancer.
Secondary
* Determine the toxicity profile of this regimen in these patients.
* Determine the progression-free and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour followed by irinotecan IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses beyond CR.
Patients are followed every 2 months until disease progression and then every 6 months thereafter.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description docetaxel + irinotecan docetaxel Patients receive docetaxel IV over 1 hour followed by irinotecan IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses beyond CR. Patients are followed every 2 months until disease progression and then every 6 months thereafter. docetaxel + irinotecan irinotecan hydrochloride Patients receive docetaxel IV over 1 hour followed by irinotecan IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 2 additional courses beyond CR. Patients are followed every 2 months until disease progression and then every 6 months thereafter.
- Primary Outcome Measures
Name Time Method Confirmed tumor response as measured by RECIST criteria Up to 5 years
- Secondary Outcome Measures
Name Time Method Overall survival Up to 5 years Distribution of progression times Up to 5 years
Trial Locations
- Locations (159)
Kenton Oncology, Incorporated
🇺🇸Kenton, Ohio, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Mercy and Unity Cancer Center at Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Miller-Dwan Medical Center
🇺🇸Duluth, Minnesota, United States
Geisinger Medical Group - Scenery Park
🇺🇸State College, Pennsylvania, United States
Northwest Ohio Oncology Center
🇺🇸Maumee, Ohio, United States
Allegheny Cancer Center at Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
Kewanee Hospital
🇺🇸Kewanee, Illinois, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
🇺🇸Peoria, Illinois, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
Cedar Rapids Oncology Associates
🇺🇸Cedar Rapids, Iowa, United States
HealthEast Cancer Care at St. John's Hospital
🇺🇸Maplewood, Minnesota, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
Minnesota Oncology Hematology, PA - Woodbury
🇺🇸Woodbury, Minnesota, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Hickman Cancer Center at Bixby Medical Center
🇺🇸Adrian, Michigan, United States
St. Charles Mercy Hospital
🇺🇸Oregon, Ohio, United States
CCOP - MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Fulton County Health Center
🇺🇸Wauseon, Ohio, United States
Mid Dakota Clinic, P. C.
🇺🇸Bismarck, North Dakota, United States
St. Alexius Medical Center
🇺🇸Bismarck, North Dakota, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
St. Joseph's Medical Center
🇺🇸Brainerd, Minnesota, United States
Fremont Memorial Hospital
🇺🇸Fremont, Ohio, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
🇺🇸Robbinsdale, Minnesota, United States
Coborn Cancer Center
🇺🇸Saint Cloud, Minnesota, United States
Cancer Resource Center - Lincoln
🇺🇸Lincoln, Nebraska, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
United States Air Force Medical Center - Wright-Patterson
🇺🇸Wright-Patterson Afb, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Minnesota Oncology Hematology, PA at Maplewood Cancer Center
🇺🇸Maplewood, Minnesota, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Adult and Pediatric Urology, P.L.L.P.
🇺🇸Sartell, Minnesota, United States
St. Joseph's Hospital
🇺🇸St Paul, Minnesota, United States
Bismarck Cancer Center
🇺🇸Bismarck, North Dakota, United States
Wood County Oncology Center
🇺🇸Bowling Green, Ohio, United States
Cancer Care Center at Medcenter One Hospital
🇺🇸Bismarck, North Dakota, United States
Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
CentraCare Clinic - River Campus
🇺🇸St. Cloud, Minnesota, United States
United Hospital
🇺🇸St. Paul, Minnesota, United States
North Coast Cancer Care, Incorporated
🇺🇸Sandusky, Ohio, United States
Medical University of Ohio Cancer Center
🇺🇸Toledo, Ohio, United States
Flower Hospital Cancer Center
🇺🇸Sylvania, Ohio, United States
Middletown Regional Hospital
🇺🇸Middletown, Ohio, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
🇺🇸Tulsa, Oklahoma, United States
Toledo Hospital
🇺🇸Toledo, Ohio, United States
Sioux Valley Hospital and University of South Dakota Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Lima Memorial Hospital
🇺🇸Lima, Ohio, United States
Toledo Clinic - Oregon
🇺🇸Oregon, Ohio, United States
Firelands Regional Medical Center
🇺🇸Sandusky, Ohio, United States
Mercy Hospital of Tiffin
🇺🇸Tiffin, Ohio, United States
Central Wisconsin Cancer Program at Agnesian HealthCare
🇺🇸Fond du Lac, Wisconsin, United States
Medical X-Ray Center, PC
🇺🇸Sioux Falls, South Dakota, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
Hutchinson Area Health Care
🇺🇸Hutchinson, Minnesota, United States
Chippewa County - Montevideo Hospital
🇺🇸Montevideo, Minnesota, United States
Hennepin County Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Saint Francis Cancer Center
🇺🇸Shakopee, Minnesota, United States
Woodwinds Health Campus
🇺🇸Woodbury, Minnesota, United States
Park Nicollet Health Services
🇺🇸St. Louis Park, Minnesota, United States
Regions Hospital Cancer Care Center
🇺🇸St. Paul, Minnesota, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
Foote Hospital
🇺🇸Jackson, Michigan, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
McFarland Clinic, PC
🇺🇸Ames, Iowa, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Seton Cancer Institute - Saginaw
🇺🇸Saginaw, Michigan, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
Meeker County Memorial Hospital
🇺🇸Lichfield, Minnesota, United States
MeritCare Medical Group
🇺🇸Fargo, North Dakota, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
🇺🇸Ottawa, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Ottumwa Regional Health Center Cancer Center
🇺🇸Ottumwa, Iowa, United States
Galesburg Clinic
🇺🇸Galesburg, Illinois, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
St. Luke's Hospital
🇺🇸Maumee, Ohio, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Medical Oncology and Hematology Associates - West Des Moines
🇺🇸West Des Moines, Iowa, United States
Siouxland Regional Cancer Center
🇺🇸Sioux City, Iowa, United States
Mercy Regional Cancer Center at Mercy Medical Center
🇺🇸Cedar Rapids, Iowa, United States
Reid Hospital & Health Care Services, Incorporated
🇺🇸Richmond, Indiana, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Immanuel St. Joseph's Clinic
🇺🇸Mankato, Minnesota, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
St. Mary's - Duluth Clinic Cancer Center
🇺🇸Duluth, Minnesota, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
🇺🇸Lambertville, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
Community Cancer Center of Monroe
🇺🇸Monroe, Michigan, United States
Toledo Clinic, Incorporated - Main Clinic
🇺🇸Toledo, Ohio, United States
Mercy Memorial Hospital System
🇺🇸Monroe, Michigan, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
MeritCare Clinic - Bemidji
🇺🇸Bemidji, Minnesota, United States
Brainerd Medical Center
🇺🇸Brainerd, Minnesota, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital
🇺🇸Fridley, Minnesota, 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
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
Immanuel Medical Center
🇺🇸Omaha, Nebraska, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
🇺🇸Omaha, Nebraska, 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