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| Sponsor: | North Central Cancer Treatment Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00079118 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: docetaxel Drug: irinotecan hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Trial of Weekly Irinotecan and Docetaxel in Refractory Metastatic Breast Cancer |
| Estimated Enrollment: | 65 |
| Study Start Date: | April 2004 |
OBJECTIVES:
Primary
Secondary
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.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 20 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the breast
At least one unidimensionally measurable lesion
The following are not considered measurable:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Meets 1 of the following criteria:
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No prior irinotecan or docetaxel for metastatic disease
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Mayo Clinic Scottsdale | |
| Scottsdale, Arizona, United States, 85259-5499 | |
| United States, Florida | |
| Mayo Clinic - Jacksonville | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Illinois | |
| BroMenn Regional Medical Center | |
| Normal, Illinois, United States, 61761 | |
| Cancer Treatment Center at Pekin Hospital | |
| Pekin, Illinois, United States, 61554 | |
| Carle Cancer Center at Carle Foundation Hospital | |
| Urbana, Illinois, United States, 61801 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61615 | |
| Community Cancer Center | |
| Normal, Illinois, United States, 61761 | |
| Community Hospital of Ottawa | |
| Ottawa, Illinois, United States, 61350 | |
| Eureka Community Hospital | |
| Eureka, Illinois, United States, 61530 | |
| Memorial Hospital | |
| Carthage, Illinois, United States, 62321 | |
| Galesburg Cottage Hospital | |
| Galesburg, Illinois, United States, 61401 | |
| Graham Hospital | |
| Canton, Illinois, United States, 61520 | |
| Hopedale Medical Complex | |
| Hopedale, Illinois, United States, 61747 | |
| Illinois Valley Community Hospital | |
| Peru, Illinois, United States, 61354 | |
| Joliet Oncology-Hematology Associates, Limited - West | |
| Joliet, Illinois, United States, 60435 | |
| Kewanee Hospital | |
| Kewanee, Illinois, United States, 61443 | |
| Mason District Hospital | |
| Havana, Illinois, United States, 62644 | |
| McDonough District Hospital | |
| Macomb, Illinois, United States, 61455 | |
| Galesburg Clinic | |
| Galesburg, Illinois, United States, 61401 | |
| Methodist Medical Center of Illinois | |
| Peoria, Illinois, United States, 61636 | |
| Oncology Hematology Associates of Central Illinois, PC - Ottawa | |
| Ottawa, Illinois, United States, 61350 | |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | |
| Peoria, Illinois, United States, 61615 | |
| OSF St. Francis Medical Center | |
| Peoria, Illinois, United States, 61637 | |
| Proctor Hospital | |
| Peoria, Illinois, United States, 61614 | |
| Rush-Copley Cancer Care Center | |
| Aurora, Illinois, United States, 60507 | |
| St. Joseph Medical Center | |
| Bloomington, Illinois, United States, 61701 | |
| St. Margaret's Hospital | |
| Spring Valley, Illinois, United States, 61362 | |
| United States, Indiana | |
| Reid Hospital & Health Care Services, Incorporated | |
| Richmond, Indiana, United States, 47374 | |
| Saint Anthony Memorial Health Centers | |
| Michigan City, Indiana, United States, 46360 | |
| St. Francis Hospital and Health Centers - Beech Grove Campus | |
| Beech Grove, Indiana, United States, 46107 | |
| United States, Iowa | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309 | |
| Cedar Rapids Oncology Associates | |
| Cedar Rapids, Iowa, United States, 52403 | |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | |
| Des Moines, Iowa, United States, 50316-2301 | |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | |
| Des Moines, Iowa, United States, 50309 | |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | |
| Des Moines, Iowa, United States, 50314 | |
| Medical Oncology and Hematology Associates - West Des Moines | |
| West Des Moines, Iowa, United States, 50266 | |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | |
| Des Moines, Iowa, United States, 50309 | |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | |
| Des Moines, Iowa, United States, 50314 | |
| McFarland Clinic, PC | |
| Ames, Iowa, United States, 50010 | |
| Mercy Capitol Hospital | |
| Des Moines, Iowa, United States, 50307 | |
| Mercy Medical Center - Sioux City | |
| Sioux City, Iowa, United States, 51104 | |
| Mercy Regional Cancer Center at Mercy Medical Center | |
| Cedar Rapids, Iowa, United States, 52403 | |
| Ottumwa Regional Health Center Cancer Center | |
| Ottumwa, Iowa, United States, 52501 | |
| St. Luke's Regional Medical Center | |
| Sioux City, Iowa, United States, 51104 | |
| Siouxland Regional Cancer Center | |
| Sioux City, Iowa, United States, 51101 | |
| St. Luke's Hospital | |
| Cedar Rapids, Iowa, United States, 52402 | |
| Siouxland Hematology-Oncology Associates, LLP | |
| Sioux City, Iowa, United States, 51101 | |
| United States, Kansas | |
| Associates in Womens Health, PA - North Review | |
| Wichita, Kansas, United States, 67203 | |
| Cancer Center of Kansas, PA - Kingman | |
| Kingman, Kansas, United States, 67068 | |
| Cancer Center of Kansas, PA - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Cancer Center of Kansas, PA - Winfield | |
| Winfield, Kansas, United States, 67156 | |
| Cancer Center of Kansas, PA - Dodge City | |
| Dodge City, Kansas, United States, 67801 | |
| Cancer Center of Kansas, PA - El Dorado | |
| El Dorado, Kansas, United States, 67042 | |
| Cancer Center of Kansas, PA - Medical Arts Tower | |
| Wichita, Kansas, United States, 67208 | |
| Cancer Center of Kansas, PA - Newton | |
| Newton, Kansas, United States, 67114 | |
| Cancer Center of Kansas, PA - Parsons | |
| Parsons, Kansas, United States, 67357 | |
| Cancer Center of Kansas, PA - Pratt | |
| Pratt, Kansas, United States, 67124 | |
| Cancer Center of Kansas, PA - Salina | |
| Salina, Kansas, United States, 67042 | |
| Cancer Center of Kansas, PA - Wellington | |
| Wellington, Kansas, United States, 67152 | |
| Cancer Center of Kansas, PA - Chanute | |
| Chanute, Kansas, United States, 66720 | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Southwest Medical Center | |
| Liberal, Kansas, United States, 67901 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| United States, Michigan | |
| CCOP - Michigan Cancer Research Consortium | |
| Ann Arbor, Michigan, United States, 48106 | |
| Community Cancer Center of Monroe | |
| Monroe, Michigan, United States, 48162 | |
| Hurley Medical Center | |
| Flint, Michigan, United States, 48503 | |
| Genesys Hurley Cancer Institute | |
| Flint, Michigan, United States, 48503 | |
| Haematology-Oncology Associates of Ohio and Michigan, PC | |
| Lambertville, Michigan, United States, 48144 | |
| Hickman Cancer Center at Bixby Medical Center | |
| Adrian, Michigan, United States, 49221 | |
| Foote Hospital | |
| Jackson, Michigan, United States, 49201 | |
| Mercy Memorial Hospital System | |
| Monroe, Michigan, United States, 48162 | |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | |
| Dearborn, Michigan, United States, 48123-2500 | |
| Seton Cancer Institute - Saginaw | |
| Saginaw, Michigan, United States, 48601 | |
| Sparrow Regional Cancer Center | |
| Lansing, Michigan, United States, 48909 | |
| St. John Macomb Hospital | |
| Warren, Michigan, United States, 48093 | |
| St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | |
| Ann Arbor, Michigan, United States, 48106-0995 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| United States, Minnesota | |
| Adult and Pediatric Urology, P.L.L.P. | |
| Sartell, Minnesota, United States, 56377 | |
| Brainerd Medical Center | |
| Brainerd, Minnesota, United States, 56401 | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| CentraCare Clinic - River Campus | |
| St. Cloud, Minnesota, United States, 56303 | |
| Chippewa County - Montevideo Hospital | |
| Montevideo, Minnesota, United States, 56265 | |
| Coborn Cancer Center | |
| Saint Cloud, Minnesota, United States, 56303 | |
| Fairview Ridges Hospital | |
| Burnsville, Minnesota, United States, 55337 | |
| Fairview Southdale Hospital | |
| Edina, Minnesota, United States, 55435 | |
| HealthEast Cancer Care at St. John's Hospital | |
| Maplewood, Minnesota, United States, 55109 | |
| Hennepin County Medical Center - Minneapolis | |
| Minneapolis, Minnesota, United States, 55415 | |
| Hubert H. Humphrey Cancer Center at North Memorial Medical Center | |
| Robbinsdale, Minnesota, United States, 55422-2900 | |
| Hutchinson Area Health Care | |
| Hutchinson, Minnesota, United States, 55350 | |
| Immanuel St. Joseph's Clinic | |
| Mankato, Minnesota, United States, 56002 | |
| Regions Hospital Cancer Care Center | |
| St. Paul, Minnesota, United States, 55101 | |
| Meeker County Memorial Hospital | |
| Lichfield, Minnesota, United States, 55355 | |
| Mercy and Unity Cancer Center at Mercy Hospital | |
| Coon Rapids, Minnesota, United States, 55433 | |
| Mercy and Unity Cancer Center at Unity Hospital | |
| Fridley, Minnesota, United States, 55432 | |
| MeritCare Clinic - Bemidji | |
| Bemidji, Minnesota, United States, 56601 | |
| Miller-Dwan Medical Center | |
| Duluth, Minnesota, United States, 55805 | |
| Minnesota Oncology Hematology, PA - Woodbury | |
| Woodbury, Minnesota, United States, 55125 | |
| Minnesota Oncology Hematology, PA at Maplewood Cancer Center | |
| Maplewood, Minnesota, United States, 55109 | |
| Park Nicollet Health Services | |
| St. Louis Park, Minnesota, United States, 55416 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| Ridgeview Medical Center | |
| Waconia, Minnesota, United States, 55387 | |
| Saint Francis Cancer Center | |
| Shakopee, Minnesota, United States, 55379 | |
| St. Joseph's Hospital | |
| St Paul, Minnesota, United States, 55102 | |
| St. Joseph's Medical Center | |
| Brainerd, Minnesota, United States, 56401 | |
| St. Mary's - Duluth Clinic Cancer Center | |
| Duluth, Minnesota, United States, 55805 | |
| Woodwinds Health Campus | |
| Woodbury, Minnesota, United States, 55125 | |
| Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | |
| Minneapolis, Minnesota, United States, 55407 | |
| Fergus Falls, Minnesota, United States, 56537 | |
| Alexandria, Minnesota, United States, 56308 | |
| United Hospital | |
| St. Paul, Minnesota, United States, 55102 | |
| United States, Nebraska | |
| Alegant Health Cancer Center at Bergan Mercy Medical Center | |
| Omaha, Nebraska, United States, 68124 | |
| Cancer Resource Center - Lincoln | |
| Lincoln, Nebraska, United States, 68510 | |
| CCOP - Missouri Valley Cancer Consortium | |
| Omaha, Nebraska, United States, 68106 | |
| Creighton University Medical Center | |
| Omaha, Nebraska, United States, 68131-2197 | |
| Immanuel Medical Center | |
| Omaha, Nebraska, United States, 68122 | |
| United States, North Dakota | |
| Mid Dakota Clinic, P. C. | |
| Bismarck, North Dakota, United States, 58501 | |
| Cancer Care Center at Medcenter One Hospital | |
| Bismarck, North Dakota, United States, 58501 | |
| CCOP - MeritCare Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| MeritCare Medical Group | |
| Fargo, North Dakota, United States, 58122 | |
| Bismarck Cancer Center | |
| Bismarck, North Dakota, United States, 58501 | |
| St. Alexius Medical Center | |
| Bismarck, North Dakota, United States, 58502 | |
| United States, Ohio | |
| Blanchard Valley Medical Associates | |
| Findlay, Ohio, United States, 45840 | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| CCOP - Toledo Community Hospital | |
| Toledo, Ohio, United States, 43623 | |
| Charles F. Kettering Memorial Hospital | |
| Kettering, Ohio, United States, 45429 | |
| David L. Rike Cancer Center at Miami Valley Hospital | |
| Dayton, Ohio, United States, 45409 | |
| Firelands Regional Medical Center | |
| Sandusky, Ohio, United States, 44870 | |
| Flower Hospital Cancer Center | |
| Sylvania, Ohio, United States, 43560 | |
| Fremont Memorial Hospital | |
| Fremont, Ohio, United States, 43420 | |
| Fulton County Health Center | |
| Wauseon, Ohio, United States, 43567 | |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | |
| Xenia, Ohio, United States, 45385 | |
| Grandview Hospital | |
| Dayton, Ohio, United States, 45405 | |
| Kenton Oncology, Incorporated | |
| Kenton, Ohio, United States, 43326 | |
| Lima Memorial Hospital | |
| Lima, Ohio, United States, 45804 | |
| Medical University of Ohio Cancer Center | |
| Toledo, Ohio, United States, 43614 | |
| Mercy Hospital of Tiffin | |
| Tiffin, Ohio, United States, 44883 | |
| Middletown Regional Hospital | |
| Middletown, Ohio, United States, 45044 | |
| North Coast Cancer Care, Incorporated | |
| Sandusky, Ohio, United States, 44870 | |
| Northwest Ohio Oncology Center | |
| Maumee, Ohio, United States, 43537 | |
| Good Samaritan Hospital | |
| Dayton, Ohio, United States, 45406 | |
| Samaritan North Cancer Care Center | |
| Dayton, Ohio, United States, 45415 | |
| St. Charles Mercy Hospital | |
| Oregon, Ohio, United States, 43616 | |
| St. Luke's Hospital | |
| Maumee, Ohio, United States, 43537 | |
| St. Vincent Mercy Medical Center | |
| Toledo, Ohio, United States, 43608 | |
| Toledo Clinic - Oregon | |
| Oregon, Ohio, United States, 43616 | |
| Veterans Affairs Medical Center - Dayton | |
| Dayton, Ohio, United States, 45428 | |
| Toledo Hospital | |
| Toledo, Ohio, United States, 43606 | |
| United States Air Force Medical Center - Wright-Patterson | |
| Wright-Patterson Afb, Ohio, United States, 45433-5529 | |
| UVMC Cancer Care Center at Upper Valley Medical Center | |
| Troy, Ohio, United States, 45373-1300 | |
| Toledo Clinic, Incorporated - Main Clinic | |
| Toledo, Ohio, United States, 43623 | |
| Wood County Oncology Center | |
| Bowling Green, Ohio, United States, 43402 | |
| United States, Oklahoma | |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Pennsylvania | |
| Allegheny Cancer Center at Allegheny General Hospital | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | |
| Wilkes-Barre, Pennsylvania, United States, 18711 | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822-0001 | |
| Geisinger Medical Group - Scenery Park | |
| State College, Pennsylvania, United States, 16801 | |
| United States, South Dakota | |
| Avera Cancer Institute | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Medical X-Ray Center, PC | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Sioux Valley Hospital and University of South Dakota Medical Center | |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| United States, Wisconsin | |
| Central Wisconsin Cancer Program at Agnesian HealthCare | |
| Fond du Lac, Wisconsin, United States, 54935 | |
| Study Chair: | Edith A. Perez, MD | Mayo Clinic |
| Investigator: | Winston Tan, MD, FACP | Mayo Clinic |
More Information
| Study ID Numbers: | CDR0000354417, NCCTG-N0332 |
| Study First Received: | March 8, 2004 |
| Last Updated: | July 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00079118 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer recurrent breast cancer male breast cancer |
|
Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Irinotecan Breast Neoplasms Enzyme Inhibitors Camptothecin |
Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Therapeutic Uses Antineoplastic Agents, Phytogenic Breast Diseases |