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Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone Metastasis Predominant Metastatic Breast Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Metastatic Cancer

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Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of breast carcinoma meeting the following criteria:

- Stage IV disease

- Bone metastasis-predominant disease, defined as the presence of ≥ 1 bone
metastasis with or without nonbone (visceral or soft tissue) disease where the
number of bone metastases is at least the number of measurable visceral target
lesions

- Visceral disease that does not cause a reduction in ECOG performance status
allowed

- Must meet 1 of the following criteria:

- Measurable disease within the past 28 days

- Nonmeasurable disease with rising serum CA 15-3, CA 27-29, CEA, or CA-125
documented by 2 consecutive measurements taken ≥ 14 days apart with the most
recent measurement being within the past 42 days

- These measurements need not be consecutive, and the prior measurement could
have been months to years prior to the current measurement if the marker is
considered by the investigator to reflect disease progression

- The second serum marker value must be greater than the institution's upper
limit of normal and show ≥ a 20% increase over the first measurement

- No symptomatic brain or CNS metastases

- Prior CNS or brain metastasis allowed provided it was treated with radiotherapy
≥ 8 weeks ago

- No pleural or pericardial effusion

- Hormone receptor status known

- Estrogen receptor- and/or progesterone receptor-positive disease must have
progressed on ≥ 1 hormonal therapy in the metastatic setting

PATIENT CHARACTERISTICS:

- Male or female

- Menopausal status not specified

- Zubrod performance status 0-2

- QTc < 450 msec by EKG

- Ejection fraction ≥ 50% by MUGA or 2-dimensional echocardiogram with no significant
abnormalities within the past 12 weeks for patients on trastuzumab

- No active infection requiring systemic therapy

- No uncontrolled concurrent condition that would preclude the ability to take oral
medication, including the following:

- Nausea

- Vomiting

- Diarrhea

- Lack of physical integrity of the upper gastrointestinal tract

- Malabsorption syndrome

- No clinically significant cardiac disease, including the following:

- Congestive heart failure

- Symptomatic coronary artery disease

- Cardiac arrhythmias not well controlled

- Myocardial infarction within the past 12 months

- No concurrent active malignancy

- Prior malignancies allowed provided the patient is currently disease-free

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 3 months after
completion of study therapy

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior RankL inhibitor therapy

- No more than 1 prior cytotoxic chemotherapy for metastatic disease

- At least 3 weeks since prior chemotherapy and recovered

- At least 1 week since prior radiotherapy to non-CNS disease and recovered

- At least 3 weeks since prior and no concurrent intravenous bisphosphates (e.g.,
zoledronate)

- At least 7 days since prior and no concurrent antiplatelet agents, including any of
the following*:

- Anticoagulants (e.g., tirofiban, eptifibatide, ticlopidine)

- Aspirin or aspirin-containing combinations

- Dipyridamole

- Epoprostenol

- Clopidogrel

- Cilostazol

- Abciximab NOTE: *Nonsteroidal anti-inflammatory drugs and medically indicated
platelet-inhibiting medication allowed

- At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the
following:

- HIV protease inhibitors (e.g., amprenavir, atazanavir, fosamprenavir, indinavir,
nelfinavir, ritonavir)

- Select antibiotics (e.g., ciprofloxacin, clarithromycin, doxycycline, enoxacin,
isoniazid, telithromycin)

- Azole antifungals (e.g., itraconazole, ketoconazole, miconazole, voriconazole)

- Select anesthetics (e.g., ketamine, propofol)

- Hypericum perforatum (St. John's wort)

- Nefazodone

- Nicardipine

- Diclofenac

- Quinidine

- Imatinib mesylate

- At least 7 days since prior and no concurrent medications that prolong the QTc
interval, including any of the following:

- Antiarrhythmic agents (e.g., quinidine, procainamide, disopyramide phosphate,
amiodarone, sotalol hydrochloride, ibutilide, dofetilide)

- Antipsychotic agents (e.g., chlorpromazine, mesoridazine, thioridazine,
pimozide, haloperidol, droperidol)

- Select antibiotics (e.g., erythromycin, clarithromycin, sparfloxacin,
pentamidine)

- Narcotic analgesics (e.g., levomethadyl, methadone, domperidone)

- Calcium channel blockers (e.g., bepridil, lidoflazine)

- Antimalarial agents (e.g., halofantrine, chloroquine)

- Parasympathomimetic agents (e.g., cisapride)

- Arsenic trioxide

- No other concurrent antineoplastic therapy for breast cancer, including any of the
following:

- Radiotherapy

- Chemotherapy

- Immunotherapy

- Biologic therapy

- Hormonal therapy

- Gene therapy

- No concurrent grapefruit juice consumption

- No concurrent short-acting antacid agents within 2 hours of dasatinib administration

- Concurrent trastuzumab (Herceptin®) therapy for HER-2 positive patients allowed
provided patients have been on continuous trastuzumab for ≥ 12 weeks

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

Disease assessed every 8 weeks for up to 2 years until progression.

Safety Issue:

No

Principal Investigator

Anne F. Schott, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000520348

NCT ID:

NCT00410813

Start Date:

March 2007

Completion Date:

September 2013

Related Keywords:

  • Breast Cancer
  • Metastatic Cancer
  • stage IV breast cancer
  • male breast cancer
  • recurrent breast cancer
  • bone metastases
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Hurley Medical CenterFlint, Michigan  48503
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
MultiCare Regional Cancer Center at Tacoma General HospitalTacoma, Washington  98405
CCOP - NorthwestTacoma, Washington  98405-0986
University of California Davis Cancer CenterSacramento, California  95817
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Interlakes Oncology/Hematology PCRochester, New York  14623
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Alaska Regional Hospital Cancer CenterAnchorage, Alaska  99508
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Mount Carmel Health - West HospitalColumbus, Ohio  43222
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Eden Medical CenterCastro Valley, California  94546
Alta Bates Summit Medical Center - Summit CampusOakland, California  94609
Valley Care Medical CenterPleasanton, California  94588
Genesis Medical Center - West CampusDavenport, Iowa  52804
Genesis Regional Cancer Center at Genesis Medical CenterDavenport, Iowa  52803
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical CenterKingsport, Tennessee  37662
Danville Regional Medical CenterDanville, Virginia  24541
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
St. Francis HospitalFederal Way, Washington  98003
St. Clare HospitalLakewood, Washington  98499-0998
Providence St. Peter Hospital Regional Cancer CenterOlympia, Washington  98506
Good Samaritan Cancer CenterPuyallup, Washington  98371
Allenmore HospitalTacoma, Washington  98411-0414
Highland General HospitalOakland, California  94602
Northeast Georgia Medical CenterGainesville, Georgia  30501
Pearlman Comprehensive Cancer Center at South Georgia Medical CenterValdosta, Georgia  31603
Crossroads Cancer CenterEffingham, Illinois  62401
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Northern Montana HospitalHavre, Montana  59501
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Mary Rutan HospitalBellefontaine, Ohio  43311
Grant Medical Center Cancer CareColumbus, Ohio  43215
Knox Community HospitalMount Vernon, Ohio  43050
Mount Carmel St. Ann's Cancer CenterWesterville, Ohio  43081
Salem Hospital Regional Cancer Care ServicesSalem, Oregon  97309-5014
Southwest Virginia Regional Cancer Center at Wellmonth HealthNorton, Virginia  24273
Providence Centralia HospitalCentralia, Washington  98531-9027
Franciscan Cancer Center at St. Joseph Medical CenterTacoma, Washington  98405-3004
Rocky Mountain OncologyCasper, Wyoming  82609
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Pardee Memorial HospitalHendersonville, North Carolina  28791
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Providence Cancer CenterAnchorage, Alaska  99508
Highlands Oncology Group - SpringdaleSpringdale, Arkansas  72764
Great Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
Doctors Medical Center - San Pablo CampusSan Pablo, California  94806
Boston University Cancer Research CenterBoston, Massachusetts  02118
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Providence Cancer Center at Providence HospitalMobile, Alabama  36608
East Bay Radiation Oncology CenterCastro Valley, California  94546
Contra Costa Regional Medical CenterMartinez, California  94553-3156
Tibotec Therapeutics - Division of Ortho Biotech Products, LPMarysville, California  95901
El Camino Hospital Cancer CenterMountain View, California  94040
Larry G Strieff MD Medical CorporationOakland, California  94609
Tom K Lee, IncorporatedOakland, California  94609
Bay Area Breast Surgeons, IncorporatedOakland, California  94609
Valley Medical Oncology Consultants - PleasantonPleasanton, California  94588
AnMed Cancer CenterAnderson, South Carolina  29621
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Lovelace Medical Center - DowntownAlbuquerque, New Mexico  87102
Hematology Oncology Associates, PCAlbuquerque, New Mexico  87106
Valley Medical Oncology Consultants - Castro ValleyCastro Valley, California  94546
Valley Medical OncologyFremont, California  94538
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry CountyMartinsville, Virginia  24115
Cancer Care Center of DecaturDecatur, Illinois  62526