Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone Metastasis Predominant Metastatic Breast Cancer
OBJECTIVES:
- Compare the progression-free survival of patients with stage IV bone
metastasis-predominant breast cancer treated with 1 of 2 treatment schedules of
dasatinib.
- Compare the response rate (complete and partial, confirmed and unconfirmed) in patients
treated with these regimens.
- Compare the MUC-1 antigen response rate (CA 15-3 or CA 27-29) in patients treated with
these regimens.
- Compare the circulating tumor cell response rate in patients treated with these
regimens.
- Compare the anti-osteoclast activity, as measured by changes in bone turnover markers,
in patients treated with these regimens.
- Compare the frequency and severity of toxicities of these regimens in these patients.
- Compare the pain profiles of these patients and explore changes over time.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
concurrent trastuzumab (Herceptin®) treatment (yes vs no). Patients are randomized to 1 of 2
treatment arms.
- Arm I: Patients receive oral dasatinib once daily.
- Arm II: Patients receive oral dasatinib twice daily. In both treatment arms, treatment
continues for at least 24 weeks in the absence of disease progression or unacceptable
toxicity.
Blood samples are acquired from patients once weekly in weeks 1, 4, 8, 16, and 24. Samples
are analyzed for tumor markers, circulating tumor cells, and bone markers.
Patients complete a self-reported brief pain inventory questionnaire at baseline and once in
weeks 8, 16, and 24.
After completion of study treatment, patients are followed every 3-6 months for up to 2
years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival, with disease progression defined as an increase in measurable disease, the appearance of new lesions, and/or clinical deterioration related to disease progression
Time from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact.
Disease assessed every 8 weeks for up to 2 years until progression.
No
Anne F. Schott, MD
Study Chair
University of Michigan Cancer Center
United States: Food and Drug Administration
CDR0000520348
NCT00410813
March 2007
September 2013
Name | Location |
---|---|
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
Hurley Medical Center | Flint, Michigan 48503 |
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
St. John Macomb Hospital | Warren, Michigan 48093 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Columbus | Columbus, Ohio 43206 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
MultiCare Regional Cancer Center at Tacoma General Hospital | Tacoma, Washington 98405 |
CCOP - Northwest | Tacoma, Washington 98405-0986 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Interlakes Oncology/Hematology PC | Rochester, New York 14623 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Alaska Regional Hospital Cancer Center | Anchorage, Alaska 99508 |
William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
Big Sky Oncology | Great Falls, Montana 59405 |
St. Peter's Hospital | Helena, Montana 59601 |
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 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
University of Mississippi Cancer Clinic | Jackson, Mississippi 39216-4505 |
CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
Eden Medical Center | Castro Valley, California 94546 |
Alta Bates Summit Medical Center - Summit Campus | Oakland, California 94609 |
Valley Care Medical Center | Pleasanton, California 94588 |
Genesis Medical Center - West Campus | Davenport, Iowa 52804 |
Genesis Regional Cancer Center at Genesis Medical Center | Davenport, Iowa 52803 |
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport, Tennessee 37662 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
St. Francis Hospital | Federal Way, Washington 98003 |
St. Clare Hospital | Lakewood, Washington 98499-0998 |
Providence St. Peter Hospital Regional Cancer Center | Olympia, Washington 98506 |
Good Samaritan Cancer Center | Puyallup, Washington 98371 |
Allenmore Hospital | Tacoma, Washington 98411-0414 |
Highland General Hospital | Oakland, California 94602 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Pearlman Comprehensive Cancer Center at South Georgia Medical Center | Valdosta, Georgia 31603 |
Crossroads Cancer Center | Effingham, Illinois 62401 |
Tammy Walker Cancer Center at Salina Regional Health Center | Salina, Kansas 67401 |
Foote Memorial Hospital | Jackson, Michigan 49201 |
St. Mary Mercy Hospital | Livonia, Michigan 48154 |
St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
St. James Healthcare Cancer Care | Butte, Montana 59701 |
Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
Sletten Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
Northern Montana Hospital | Havre, Montana 59501 |
Kalispell Medical Oncology at KRMC | Kalispell, Montana 59901 |
Mary Rutan Hospital | Bellefontaine, Ohio 43311 |
Grant Medical Center Cancer Care | Columbus, Ohio 43215 |
Knox Community Hospital | Mount Vernon, Ohio 43050 |
Mount Carmel St. Ann's Cancer Center | Westerville, Ohio 43081 |
Salem Hospital Regional Cancer Care Services | Salem, Oregon 97309-5014 |
Southwest Virginia Regional Cancer Center at Wellmonth Health | Norton, Virginia 24273 |
Providence Centralia Hospital | Centralia, Washington 98531-9027 |
Franciscan Cancer Center at St. Joseph Medical Center | Tacoma, Washington 98405-3004 |
Rocky Mountain Oncology | Casper, Wyoming 82609 |
Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Providence Cancer Center | Anchorage, Alaska 99508 |
Highlands Oncology Group - Springdale | Springdale, Arkansas 72764 |
Great Falls, Montana 59405 | |
Guardian Oncology and Center for Wellness | Missoula, Montana 59804 |
Doctors Medical Center - San Pablo Campus | San Pablo, California 94806 |
Boston University Cancer Research Center | Boston, Massachusetts 02118 |
St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
Providence Cancer Center at Providence Hospital | Mobile, Alabama 36608 |
East Bay Radiation Oncology Center | Castro Valley, California 94546 |
Contra Costa Regional Medical Center | Martinez, California 94553-3156 |
Tibotec Therapeutics - Division of Ortho Biotech Products, LP | Marysville, California 95901 |
El Camino Hospital Cancer Center | Mountain View, California 94040 |
Larry G Strieff MD Medical Corporation | Oakland, California 94609 |
Tom K Lee, Incorporated | Oakland, California 94609 |
Bay Area Breast Surgeons, Incorporated | Oakland, California 94609 |
Valley Medical Oncology Consultants - Pleasanton | Pleasanton, California 94588 |
AnMed Cancer Center | Anderson, South Carolina 29621 |
University of Colorado Cancer Center at UC Health Sciences Center | Aurora, Colorado 80045 |
Lovelace Medical Center - Downtown | Albuquerque, New Mexico 87102 |
Hematology Oncology Associates, PC | Albuquerque, New Mexico 87106 |
Valley Medical Oncology Consultants - Castro Valley | Castro Valley, California 94546 |
Valley Medical Oncology | Fremont, California 94538 |
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County | Martinsville, Virginia 24115 |
Cancer Care Center of Decatur | Decatur, Illinois 62526 |