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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00041067 |
Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors, such as filgrastim, may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with docetaxel, vinorelbine, and filgrastim in treating women who have stage IV breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: filgrastim Biological: trastuzumab Drug: docetaxel Drug: vinorelbine ditartrate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Docetaxel (NSC-628503) And Vinorelbine (NSC-608210) Plus Filgrastim (NSC-614629) With Weekly Trastuzumab (NSC-688097) For HER-2 Positive, Stage IV Breast Cancer |
| Estimated Enrollment: | 90 |
| Study Start Date: | September 2002 |
OBJECTIVES:
OUTLINE: This is a pilot, multicenter study.
Patients receive docetaxel IV over 1 hour on day 1, filgrastim (G-CSF) subcutaneously on days 2-21, vinorelbine IV over 6-10 minutes on days 8 and 15, and trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. If docetaxel and vinorelbine are discontinued due to unacceptable toxicity, patients may continue to receive trastuzumab. If trastuzumab is discontinued due to unacceptable toxicity, patients may continue to receive chemotherapy with G-CSF support.
Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 18-22.5 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage IV breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Mobile Infirmary Medical Center | |
| Mobile, Alabama, United States, 36652-2144 | |
| United States, Arkansas | |
| Ben E. Owens Cancer Treatment Center at St. Bernard's Medical Center | |
| Jonesboro, Arkansas, United States, 72401-9320 | |
| Hembree Mercy Cancer Center at St. Edward Mercy Medical Center | |
| Ft. Smith, Arkansas, United States, 72903 | |
| United States, California | |
| Alta Bates Summit Medical Center - Summit Campus | |
| Oakland, California, United States, 94609 | |
| Mercy General Hospital | |
| Sacramento, California, United States, 95819 | |
| Doctors Medical Center - San Pablo Campus | |
| San Pablo, California, United States, 94806 | |
| Eden Medical Center | |
| Castro Valley, California, United States, 94546 | |
| Highland General Hospital at St. George's University School of Medicine | |
| Oakland, California, United States, 94602 | |
| CCOP - Bay Area Tumor Institute | |
| Oakland, California, United States, 94609 | |
| Saint Rose Hospital | |
| Hayward, California, United States, 94545 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| Valley Care Medical Center | |
| Pleasanton, California, United States, 94588 | |
| United States, Florida | |
| West Florida Cancer Institute at West Florida Hospital - Pensacola | |
| Pensacola, Florida, United States, 32514 | |
| United States, Idaho | |
| St. Luke's Mountain States Tumor Institute - Boise | |
| Boise, Idaho, United States, 83712 | |
| United States, Illinois | |
| Hematology Oncology Consultants - Naperville | |
| Naperville, Illinois, United States, 60540 | |
| Edward Hospital Cancer Center | |
| Naperville, Illinois, United States, 60540 | |
| Good Samaritan Regional Health Center | |
| Mt. Vernon, Illinois, United States, 62864 | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Saint Anthony's Hospital at Saint Anthony's Health Center | |
| Alton, Illinois, United States, 62002 | |
| 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 - Chanute | |
| Chanute, Kansas, United States, 66720 | |
| 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 | |
| Stormont-Vail Cancer Center | |
| Topeka, Kansas, United States, 66604 | |
| 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 - Winfield | |
| Winfield, Kansas, United States, 67156 | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Southwest Medical Center | |
| Liberal, Kansas, United States, 67901 | |
| St. Francis Comprehensive Cancer Center | |
| Topeka, Kansas, United States, 66606 | |
| Cancer Center of Kansas, PA - Parsons | |
| Parsons, Kansas, United States, 67357 | |
| Tammy Walker Cancer Center at Salina Regional Health Center | |
| Salina, Kansas, United States, 67401 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Bay Regional Medical Center | |
| Bay City, Michigan, United States, 48708 | |
| CCOP - Michigan Cancer Research Consortium | |
| Ann Arbor, Michigan, United States, 48106 | |
| Seton Cancer Institute - Saginaw | |
| Saginaw, Michigan, United States, 48601 | |
| Mercy Regional Cancer Center at Mercy Hospital | |
| Port Huron, Michigan, United States, 48060 | |
| Saint Joseph Mercy Cancer Center | |
| Ann Arbor, Michigan, United States, 48106-0995 | |
| Genesys Hurley Cancer Institute | |
| Flint, Michigan, United States, 48503 | |
| St. John Macomb Hospital | |
| Warren, Michigan, United States, 48093 | |
| Ted B. Wahby Cancer Center at Mount Clemens General Hospital | |
| Mount Clemens, Michigan, United States, 48043 | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109-0942 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| United States, Missouri | |
| CCOP - Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65802 | |
| Saint Francis Medical Center | |
| Cape Girardeau, Missouri, United States, 63701 | |
| David C. Pratt Cancer Center at St. John's Mercy | |
| Saint Louis, Missouri, United States, 63141 | |
| Hulston Cancer Center at Cox Medical Center South | |
| Springfield, Missouri, United States, 65807 | |
| CCOP - St. Louis-Cape Girardeau | |
| St. Louis, Missouri, United States, 63141 | |
| Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | |
| Gape Girardeau, Missouri, United States, 63701 | |
| St. John's Regional Health Center | |
| Springfield, Missouri, United States, 65804 | |
| United States, Montana | |
| Big Sky Oncology | |
| Great Falls, Montana, United States, 59405 | |
| Billings Clinic Cancer Center | |
| Billings, Montana, United States, 59107-5100 | |
| Bozeman Deaconess Hospital | |
| Bozeman, Montana, United States, 59715 | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| Community Medical Center | |
| Missoula, Montana, United States, 59801 | |
| Deaconess Billings Clinic - Downtown | |
| Billings, Montana, United States, 59107-7000 | |
| Glacier Oncology, PLLC | |
| Kalispell, Montana, United States, 59901 | |
| Sletten Regional Cancer Institute at Benefis Healthcare | |
| Great Falls, Montana, United States, 59405 | |
| Guardian Oncology and Center for Wellness | |
| Missoula, Montana, United States, 59804 | |
| Hematology-Oncology Centers of the Northern Rockies - Billings | |
| Billings, Montana, United States, 59101 | |
| Kalispell Medical Oncology | |
| Kalispell, Montana, United States, 59901 | |
| Kalispell Regional Medical Center | |
| Kalispell, Montana, United States, 59901 | |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | |
| Missoula, Montana, United States, 59807 | |
| Montana Cancer Specialists at Montana Cancer Center | |
| Missoula, Montana, United States, 59807-7877 | |
| Northern Rockies Radiation Oncology Center | |
| Billings, Montana, United States, 59101 | |
| Great Falls Clinic | |
| Great Falls, Montana, United States, 59405 | |
| St. James Community Hospital | |
| Butte, Montana, United States, 59701 | |
| St. Peter's Hospital | |
| Helena, Montana, United States, 59601 | |
| St. Vincent Healthcare | |
| Billings, Montana, United States, 59101 | |
| United States, Nebraska | |
| Good Samaritan Cancer Center at Good Samaritan Hospital | |
| Kearney, Nebraska, United States, 68848-1990 | |
| United States, New Jersey | |
| Valley Hospital - Ridgewood | |
| Ridgewood, New Jersey, United States, 07450 | |
| United States, New Mexico | |
| Hematology Oncology Associates, PC | |
| Albuquerque, New Mexico, United States, 87106 | |
| Lovelace Medical Center | |
| Albuquerque, New Mexico, United States, 87108 | |
| New Mexico Cancer Care Associates | |
| Santa Fe, New Mexico, United States, 87505 | |
| University of New Mexico Cancer Research and Treatment Center | |
| Albuquerque, New Mexico, United States, 87131-5636 | |
| United States, New York | |
| Highland Hospital of Rochester | |
| Rochester, New York, United States, 14620 | |
| Interlakes Oncology/Hematology PC | |
| Rochester, New York, United States, 14623 | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| Forsyth Regional Cancer Center at Forsyth Medical Center | |
| Winston-Salem, North Carolina, United States, 27103 | |
| Rutherford Hospital | |
| Rutherfordton, North Carolina, United States, 28139 | |
| Wayne Memorial Hospital, Incorporated | |
| Goldsboro, North Carolina, United States, 27534 | |
| United States, Ohio | |
| MedCentral - Mansfield Hospital | |
| Mansfield, Ohio, United States, 44903 | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Community Oncology Group at Cleveland Clinic Cancer Center | |
| Independence, Ohio, United States, 44131 | |
| Cleveland Clinic - Wooster | |
| Wooster, Ohio, United States, 44691 | |
| United States, Oregon | |
| CCOP - Columbia River Oncology Program | |
| Portland, Oregon, United States, 97225 | |
| Legacy Emanuel Hospital and Health Center & Children's Hospital | |
| Portland, Oregon, United States, 97227 | |
| Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center | |
| Portland, Oregon, United States, 97210 | |
| Legacy Meridian Park Hospital | |
| Tualatin, Oregon, United States, 97062 | |
| Legacy Mount Hood Medical Center | |
| Gresham, Oregon, United States, 97030 | |
| Providence Cancer Center at Providence Portland Medical Center | |
| Portland, Oregon, United States, 97213-2967 | |
| Providence Milwaukie Hospital | |
| Milwaukie, Oregon, United States, 97222 | |
| Providence St. Vincent Medical Center | |
| Portland, Oregon, United States, 97225 | |
| United States, South Carolina | |
| AnMed Health Cancer Center | |
| Anderson, South Carolina, United States, 29621 | |
| Bon Secours St. Francis Health System | |
| Greenville, South Carolina, United States, 29601 | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Texas | |
| Cancer Therapy and Research Center | |
| San Antonio, Texas, United States, 78229 | |
| Veterans Affairs Medical Center - San Antonio (Murphy) | |
| San Antonio, Texas, United States, 78209 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78229-3900 | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-0361 | |
| University Hospital - San Antonio | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| American Fork Hospital | |
| American Fork, Utah, United States, 84003 | |
| Cottonwood Hospital Medical Center | |
| Murray, Utah, United States, 84107 | |
| Dixie Regional Medical Center - East Campus | |
| Saint George, Utah, United States, 84770 | |
| Huntsman Cancer Institute at University of Utah | |
| Salt Lake City, Utah, United States, 84112 | |
| Latter Day Saints Hospital | |
| Salt Lake City, Utah, United States, 84103 | |
| Utah Valley Regional Medical Center - Provo | |
| Provo, Utah, United States, 84604 | |
| McKay-Dee Hospital Center | |
| Ogden, Utah, United States, 84403 | |
| Utah Cancer Specialists at UCS Cancer Center | |
| Salt Lake City, Utah, United States, 84106 | |
| Logan Regional Hospital | |
| Logan, Utah, United States, 84321 | |
| United States, Virginia | |
| Danville Regional Medical Center | |
| Danville, Virginia, United States, 24541 | |
| United States, Washington | |
| Allenmore Hospital | |
| Tacoma, Washington, United States, 98405 | |
| Auburn Regional Center for Cancer Care | |
| Auburn, Washington, United States, 98002 | |
| Cancer Care Northwest - Spokane South | |
| Spokane, Washington, United States, 99202 | |
| Capital Medical Center | |
| Olympia, Washington, United States, 98507 | |
| Group Health Central Hospital | |
| Seattle, Washington, United States, 98112 | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98104 | |
| Good Samaritan Cancer Center | |
| Puyallup, Washington, United States, 98372 | |
| CCOP - Northwest | |
| Tacoma, Washington, United States, 98405 | |
| Harborview Medical Center | |
| Seattle, Washington, United States, 98104 | |
| Minor and James Medical, PLLC | |
| Seattle, Washington, United States, 98104 | |
| MultiCare Regional Cancer Center at Tacoma General Hospital | |
| Tacoma, Washington, United States, 98405 | |
| North Puget Oncology at United General Hospital | |
| Sedro-Wooley, Washington, United States, 98284 | |
| Olympic Hematology and Oncology | |
| Bremerton, Washington, United States, 98310 | |
| Skagit Valley Hospital Cancer Care Center | |
| Mt. Vernon, Washington, United States, 98273 | |
| Providence Centralia Hospital Regional Cancer Center | |
| Centralia, Washington, United States, 98531-9027 | |
| Providence St. Peter Hospital Regional Cancer Center | |
| Olympia, Washington, United States, 98506-5166 | |
| Polyclinic First Hill | |
| Seattle, Washington, United States, 98122 | |
| Southwest Washington Medical Center Cancer Center | |
| Vancouver, Washington, United States, 98668 | |
| St. Clare Hospital | |
| Tacoma, Washington, United States, 98499 | |
| St. Francis Hospital | |
| Federal Way, Washington, United States, 98003 | |
| St. Joseph Cancer Center | |
| Bellingham, Washington, United States, 98225 | |
| St. Joseph Medical Center at Franciscan Health System | |
| Tacoma, Washington, United States, 98405-3004 | |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | |
| Seattle, Washington, United States, 98122-4307 | |
| University Cancer Center at University of Washington Medical Center | |
| Seattle, Washington, United States, 98195-6043 | |
| Wenatchee Valley Medical Center | |
| Wenatchee, Washington, United States, 98801-2028 | |
| United States, Wyoming | |
| Welch Cancer Center at Sheridan Memorial Hospital | |
| Sheridan, Wyoming, United States, 82801 | |
| Study Chair: | Joseph J. Kash, MD | Edward Hospital Cancer Center |
More Information
| Study ID Numbers: | CDR0000069440, SWOG-S0215 |
| Study First Received: | July 8, 2002 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00041067 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer recurrent breast cancer |
|
Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Mitosis Modulators Breast Neoplasms Vinblastine Antimitotic Agents Pharmacologic Actions Docetaxel |
Neoplasms Neoplasms by Site Vinorelbine Therapeutic Uses Tubulin Modulators Trastuzumab Antineoplastic Agents, Phytogenic Breast Diseases |