Docetaxel (NSC-628503) And Vinorelbine (NSC-608210) Plus Filgrastim (NSC-614629) With Weekly Trastuzumab (NSC-688097) For HER-2 Positive, Stage IV Breast Cancer
OBJECTIVES:
- Determine the 1-year survival of women with HER2-positive stage IV breast cancer
treated with trastuzumab (Herceptin), docetaxel, and vinorelbine with filgrastim
(G-CSF) support.
- Determine the response rate (complete and partial, confirmed and unconfirmed) in the
subset of patients with measurable disease treated with this regimen.
- Determine the progression-free survival of patients treated with this regimen.
- Determine the qualitative and quantitative toxic effects of this regimen in these
patients.
- Obtain tissue blocks for the determination of predictors of response (e.g.,
beta-tubulin mutations) to microtubule interacting agents in this patient population
and for other future studies.
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Survival at 1 Year
1 year
No
Joseph J. Kash, MD
Study Chair
Edward Hospital Cancer Center
United States: Federal Government
CDR0000069440
NCT00041067
September 2002
January 2012
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Seton Cancer Institute - Saginaw | Saginaw, Michigan 48601 |
St. John Macomb Hospital | Warren, Michigan 48093 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Greenville | Greenville, South Carolina 29615 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
MultiCare Regional Cancer Center at Tacoma General Hospital | Tacoma, Washington 98405 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
CCOP - Northwest | Tacoma, Washington 98405-0986 |
Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
University of California Davis Cancer Center | Sacramento, California 95817 |
University of New Mexico Cancer Research and Treatment Center | Albuquerque, New Mexico 87131 |
Mobile Infirmary Medical Center | Mobile, Alabama 36640-0460 |
Great Falls Clinic | Great Falls, Montana 59405 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
Latter Day Saints Hospital | Salt Lake City, Utah 84143 |
St. Luke's Mountain States Tumor Institute - Boise | Boise, Idaho 83712-6297 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Legacy Emanuel Hospital and Health Center & Children's Hospital | Portland, Oregon 97227 |
Interlakes Oncology/Hematology PC | Rochester, New York 14623 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Saint Anthony's Hospital at Saint Anthony's Health Center | Alton, Illinois 62002 |
Good Samaritan Regional Health Center | Mt. Vernon, Illinois 62864 |
Southwest Medical Center | Liberal, Kansas 67901 |
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital | Gape Girardeau, Missouri 63701 |
David C. Pratt Cancer Center at St. John's Mercy | St. Louis, Missouri 63141 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
St. Vincent Healthcare | Billings, Montana 59101 |
Deaconess Billings Clinic - Downtown | Billings, Montana 59101 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
St. James Community Hospital | Butte, Montana 59701 |
Big Sky Oncology | Great Falls, Montana 59405 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Medical Oncology | Kalispell, Montana 59901 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Community Medical Center | Missoula, Montana 59801 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
American Fork Hospital | American Fork, Utah 84003 |
Logan Regional Hospital | Logan, Utah 84321 |
Cottonwood Hospital Medical Center | Murray, Utah 84107 |
McKay-Dee Hospital Center | Ogden, Utah 84403 |
Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
Olympic Hematology and Oncology | Bremerton, Washington 98310 |
Skagit Valley Hospital Cancer Care Center | Mt. Vernon, Washington 98273 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Harborview Medical Center | Seattle, Washington 98104 |
Group Health Central Hospital | Seattle, Washington 98104 |
North Puget Oncology at United General Hospital | Sedro-Wooley, Washington 98284 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
Eden Medical Center | Castro Valley, California 94546 |
Saint Rose Hospital | Hayward, California 94545 |
Highland General Hospital at St. George's University School of Medicine | Oakland, California 94602 |
Alta Bates Summit Medical Center - Summit Campus | Oakland, California 94609 |
Valley Care Medical Center | Pleasanton, California 94588 |
Edward Hospital Cancer Center | Naperville, Illinois 60540 |
Hematology Oncology Consultants - Naperville | Naperville, Illinois 60540 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Stormont-Vail Cancer Center | Topeka, Kansas 66604 |
St. Francis Comprehensive Cancer Center | Topeka, Kansas 66606 |
Bay Regional Medical Center | Bay City, Michigan 48708 |
Saint Francis Medical Center | Cape Girardeau, Missouri 63701 |
Highland Hospital of Rochester | Rochester, New York 14620 |
Forsyth Regional Cancer Center at Forsyth Medical Center | Winston-Salem, North Carolina 27103 |
Community Oncology Group at Cleveland Clinic Cancer Center | Independence, Ohio 44131 |
Cleveland Clinic - Wooster | Wooster, Ohio 44691 |
Legacy Mount Hood Medical Center | Gresham, Oregon 97030 |
Providence Milwaukie Hospital | Milwaukie, Oregon 97222 |
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center | Portland, Oregon 97210 |
Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
Providence St. Vincent Medical Center | Portland, Oregon 97225 |
Legacy Meridian Park Hospital | Tualatin, Oregon 97062 |
Bon Secours St. Francis Health System | Greenville, South Carolina 29601 |
Cancer Therapy and Research Center | San Antonio, Texas 78229 |
University Hospital - San Antonio | San Antonio, Texas 78229 |
Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Minor and James Medical, PLLC | Seattle, Washington 98104 |
Polyclinic First Hill | Seattle, Washington 98122 |
Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
St. Francis Hospital | Federal Way, Washington 98003 |
St. Clare Hospital | Lakewood, Washington 98499-0998 |
Capital Medical Center | Olympia, Washington 98502 |
Providence St. Peter Hospital Regional Cancer Center | Olympia, Washington 98506 |
Good Samaritan Cancer Center | Puyallup, Washington 98371 |
St. Joseph Medical Center at Franciscan Health System | Tacoma, Washington 98405-3004 |
Allenmore Hospital | Tacoma, Washington 98411-0414 |
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center | Ft. Smith, Arkansas 72903 |
West Florida Cancer Institute at West Florida Hospital - Pensacola | Pensacola, Florida 32514 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Tammy Walker Cancer Center at Salina Regional Health Center | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
St. Joseph Cancer Center | Bellingham, Washington 98225 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Auburn Regional Center for Cancer Care | Auburn, Washington 98002 |
Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney, Nebraska 68848-1990 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
AnMed Health Cancer Center | Anderson, South Carolina 29621 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
MedCentral - Mansfield Hospital | Mansfield, Ohio 44903 |
New Mexico Cancer Care Associates | Santa Fe, New Mexico 87505-7670 |
Billings Clinic Cancer Center | Billings, Montana 59107-5100 |
Sletten Regional Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
Doctors Medical Center - San Pablo Campus | San Pablo, California 94806 |
Mercy General Hospital | Sacramento, California 95819 |
Valley Hospital - Ridgewood | Ridgewood, New Jersey 07450 |
Ted B. Wahby Cancer Center at Mount Clemens General Hospital | Mount Clemens, Michigan 48043 |
Lovelace Medical Center | Albuquerque, New Mexico 87108 |
Providence Centralia Hospital Regional Cancer Center | Centralia, Washington 98531 |
Ben E. Owens Cancer Treatment Center at St. Bernard's Medical Center | Jonesboro, Arkansas 72401-9320 |
Hematology Oncology Associates, PC | Albuquerque, New Mexico 87106 |