Overview

Abiraterone Acetate and Prednisone With or Without Dasatinib in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

Status:
Unknown status
Trial end date:
2018-03-01
Target enrollment:
0
Participant gender:
Male
Summary
This phase II trial studies how well giving abiraterone acetate and prednisone with or without dasatinib works in treating patients with metastatic, hormone-resistant prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as abiraterone acetate, may lessen the amount of androgens made by the body. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether abiraterone acetate and prednisone is more effective than abiraterone acetate, prednisone, and dasatinib in treating prostate cancer
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Southern California
Collaborator:
National Cancer Institute (NCI)
Treatments:
Abiraterone Acetate
Dasatinib
Prednisone
Criteria
Inclusion Criteria:

- Metastatic, castration-resistant prostate cancer

- Defined as evaluable radiographic disease with rising PSA x 2 (at least 1 week
apart) or radiographic progression (new soft tissue/bone lesions or enlarging
soft tissue lesions) despite medical or surgical castration

- No limit on prior hormonal therapies (i.e. anti-androgens, ketoconazole) except
that subject must not have received abiraterone previously

- No limit on prior biologic therapies (i.e. immune therapy, antiangiogenic,
targeted) except that patient should not have received dasatinib or other v-src
sarcoma (Schmidt-Ruppin A-2) viral oncogene homolog (avian) (src)-targeted
therapy

- No prior chemotherapy for metastatic disease

* Subjects who have received chemotherapy in the neoadjuvant or adjuvant setting will
be eligible provided chemotherapy was completed > 6 months prior to enrollment

- Eastern Cooperative Oncology Group (ECOG) 0-2

- Total bilirubin =< 1.5 times the institutional upper limit of normal (ULN) except for
Gilbert's syndrome

- Hepatic enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT] ) =<
2.5 times the institutional ULN

- Serum sodium (Na), potassium (K+), magnesium (Mg+), phosphate and calcium (Ca+) >
lower limit of normal (LLN)

- Serum creatinine =< 1.5 time the institutional ULN

- Hemoglobin (Hb) >= 9

- Platelets >= 100,000

- Absolute neutrophil count (ANC) >= 1000

- Ability to take oral medication (study medications must be swallowed whole)

- Men with fathering potential must agree to use contraception throughout study
treatment; acceptable methods include: condoms, sponge, intrauterine device (IUD),
oral contraceptives

- Concomitant medications * Patient agrees to discontinue St. Johns wort while receiving
dasatinib therapy (discontinue St. Johns wort at least 5 days before starting
dasatinib)

Exclusion Criteria:

- Known hepatitis B or C or human immunodeficiency virus (HIV), regardless of viral load

* Testing for the purposes of enrollment is not mandatory, however a documented
history of these infections will be exclusionary due to concerns for drug-drug
interactions with antivirals and potential for increased risk of liver toxicity

- Radiation for palliation of bony metastases within the preceding 2 weeks

- Prior chemotherapy for metastatic castration-resistant prostate cancer (CRPC)

* Immune therapy with sipuleucel-T is allowed, provided the last infusion was >= 28
days prior to study therapy and there has been at least one documented PSA value
rising after completion of sipuleucel-T therapy or progression of disease on imaging
after sipuleucel-T

- Malignancy (aside from prostate cancer) which required radiotherapy or systemic
treatment within the past 5 years

- Superficial bladder cancer treated with intravesical therapy and currently in
remission will not be an exclusion

- Skin cancers will not be an exclusion, except for melanoma with a thickness > 1
mm

- Concurrent medical condition which may increase the risk of toxicity, including:

- Pleural or pericardial effusion of any grade at the time of study entry

- Cardiac symptoms; any of the following should be considered for exclusion: **
Uncontrolled angina, congestive heart failure or myocardial infarction (MI)
within (6 months)

- Diagnosed congenital long QT syndrome

- Any history of clinically significant ventricular arrhythmias (such as
ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
** Prolonged QTc/f interval on pre-entry electrocardiogram (> 450 msec)

- Hypokalemia or hypomagnesemia if it cannot be corrected prior to abiraterone
administration

- History of significant bleeding disorder unrelated to cancer, including:

- Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)

- Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor
VIII antibodies)

- Ongoing or recent (=< 3 months) significant gastrointestinal bleeding

- Prohibited treatments and/or therapies

- Should not be on any additional anti-cancer therapy except for luteinizing
hormone-releasing hormone (LHRH) agonist/antagonist; specifically excluded
medications include ketoconazole, estrogens, and anti-androgens

- Category I drugs that are generally accepted to have a risk of causing Torsades
de pointes including: (Patients must discontinue drug 7 days prior to starting
dasatinib)

- Quinidine, procainamide, disopyramide

- Amiodarone, sotalol, ibutilide, dofetilide

- Erythromycin, clarithromycin

- Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide

- Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine,
domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin,
lidoflazine

- Prisoners or subjects who are involuntarily incarcerated

- Subjects who are compulsorily detained for treatment of either a psychiatric or
physical (eg, infectious disease) illness