Observational Study of Docetaxel Exposure in Metastatic Prostate Cancer Patients



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2015
End Date:August 2018
Contact:Craig Miller, BS
Email:cmiller@saladax.com
Phone:484-547-0540

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Observational Study of Metastatic Prostate Cancer Subjects Receiving Docetaxel Therapy for Evaluation of Docetaxel Plasma Levels Using the MyDocetaxel Assay

In this observational study, blood samples for pharmacokinetic (PK) testing will be
collected from subjects with metastatic prostate cancer during their treatment with
docetaxel. Plasma levels of docetaxel will be determined, and the subjects docetaxel
exposure levels, determined as an area under the curve (AUC), will be retrospectively
correlated with reports of toxicity, tumor response, quality of life, time to disease
progression and overall survival to provide guidance on what the appropriate target range
for docetaxel exposure should be for metastatic prostate cancer subjects receiving docetaxel
therapy for their disease.


Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the
prostate.

- Male subjects 18 years of age or older.

- About to start a new line of treatment with docetaxel (75 mg/m2) in combination with
prednisone.

- All subjects must be informed of the investigational nature of this study and be
willing to provide written informed consent in accordance with Institutional
guidelines and good clinical practices (GCP) indicating that they understand the
purpose of and procedures required for the study and are willing to participate in
the study prior to the beginning of specific study procedures.

- Prior surgical castration or concurrent use of an agent for chemical castration with
a serum testosterone level < 50 ng/dL.

- Subjects with hormone naïve metastatic prostate cancer, must have high-volume
disease, defined as extra-nodal visceral disease or bone metastases with at least 4
bone lesions (one being outside of the vertebral column or pelvis).

- Subjects with hormone naïve high-volume metastatic prostate adenocarcinoma must have
been on androgen deprivation therapy (including luteinizing hormone-releasing hormone
(LHRH) agonist therapy, LHRH antagonist therapy, or surgical castration) for less
than 120 days prior to starting docetaxel therapy.

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

- For subjects with castrate resistant prostate cancer (CRPC), at least four weeks
elapsed between withdrawal of anti-androgens (Bicalutamide, Flutamide or Nilutamide)
and initiation of docetaxel therapy.

- For subjects with CRPC, at least four weeks elapsed between last administration of
Abiraterone (Zytiga®) or Enzalutamide (Xtandi®) and initiation of docetaxel therapy.

- At least four weeks elapsed between prior surgery or prior radiotherapy and
initiation of docetaxel therapy.

- Radiograph-documented evidence of soft tissue or bony metastatic disease.

- Must have adequate hematologic, hepatic and renal function as defined below:

- Hematologic (minimal values): Absolute neutrophil count ≥ 1,500/mm3; Hemoglobin ≥
10.0 g/dl; Platelet count ≥ 75,000/mm3

- Hepatic Function: Total Bilirubin ≤ 1.5 x institutional upper limit of normal (ULN);
asparate transaminase (AST) and alanine transaminase (ALT) < 2 x institutional ULN

- Suitable venous access and healthy enough (as determined by the treating physician)
to provide whole blood sample.

Exclusion Criteria:

- Any condition / concomitant disease not allowing chemotherapy with docetaxel,
prednisone or required premedication for the treatment regimen.

- Serious concurrent disorders (active infection requiring intravenous antibiotics,
unstable angina, uncompensated congestive heart failure (CHF), or hepatic failure)
that, in the opinion of the investigator, would prevent the use of docetaxel and/or
compromise the subject's ability to provide whole blood samples for participation in
the study.

- Concurrent use of any non-FDA approved (i.e. investigational or experimental)
anticancer agent(s) or within four (4) weeks of enrolling on the study.

- Pre-existing neuropathy ≥ grade 2 per the National Cancer Institute Common
Terminology Criteria for Adverse Events (NCI CTCAE) version 4.

- Individuals with known seropositivity for human immunodeficiency virus (HIV),
hepatitis C virus, hepatitis B surface antigen, or syphilis.

- Unwilling or unable to follow protocol requirements or to provide informed consent.
We found this trial at
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Pittsburgh, Pennsylvania 15237
Phone: 412-748-6027
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Beaver, Pennsylvania 15009
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Bethel Park, Pennsylvania 15102
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Farrell, Pennsylvania 16121
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Greensburg, Pennsylvania 15601
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Greensburg, Pennsylvania 15601
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Greenville, Pennsylvania 16125
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Indiana, Pennsylvania 15701
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Johnstown, Pennsylvania 15901
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McKeesport, Pennsylvania 15132
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Monroeville, Pennsylvania 15146
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Mount Pleasant, Pennsylvania 15666
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New Castle, Pennsylvania 16105
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Pittsburgh, Pennsylvania 15215
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Pittsburgh, Pennsylvania 15232
Principal Investigator: Leonard J Appleman, MD, PhD
Phone: 412-623-8962
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Pittsburgh, Pennsylvania 15237
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Seneca, Pennsylvania 16346
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Uniontown, Pennsylvania 15401
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Washington, Pennsylvania 15301
Phone: 724-223-3816
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West Mifflin, Pennsylvania 15122
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