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Observational Study of Docetaxel Exposure in Metastatic Prostate Cancer Patients

Information source: Saladax Biomedical, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: docetaxel (Drug); Blood draws (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Saladax Biomedical, Inc.

Official(s) and/or principal investigator(s):
Rahul A Parikh, MD, PhD, Principal Investigator, Affiliation: UPMC CancerCenter

Overall contact:
Craig Miller, BS, Phone: 484-547-0540, Email: cmiller@saladax.com

Summary

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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Variability of docetaxel exposure

Docetaxel treatment related toxicities

Secondary outcome:

Frequency of growth factor usage

Number of days hospitalized for treatment of docetaxel related toxicities

Time to prostate specific antigen (PSA) progression

Tumor response as determined by imaging

Changes in quality of life

Overall survival

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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.

Locations and Contacts

Craig Miller, BS, Phone: 484-547-0540, Email: cmiller@saladax.com

UPMC CancerCenter - Beaver, Beaver, Pennsylvania 15009, United States; Recruiting
Karen Flanagan, Phone: 724-371-3852, Email: flanagankd@upmc.edu
William Ferri, MD, Sub-Investigator
Stewart Lancaster, MD, Sub-Investigator
Grace R Tarabay, MD, Sub-Investigator

UPMC CancerCenter - Upper St. Clair, Bethel Park, Pennsylvania 15102, United States; Recruiting
Rita Pfrimmer, Phone: 412-831-7096, Email: pfrimmerra@upmc.edu
Ronald Fierro, MD, Sub-Investigator
Vincent E Reyes, Jr., MD, Sub-Investigator
Robert VanderWeele, MD, Sub-Investigator
Robert Volkin, MD, Sub-Investigator

UPMC CancerCenter - Horizon, Farrell, Pennsylvania 16121, United States; Recruiting
Kristy Thompson, Phone: 814-676-7881, Email: thompsonk15@upmc.edu
William Spielvogel, MD, Sub-Investigator

Arnold Palmer Cancer Center, Greensburg, Pennsylvania 15601, United States; Recruiting
Amy Alfery, Phone: 724-838-5693, Email: alferyas@upmc.edu
Terry Evans, MD, Sub-Investigator
Gauri Kiefer, MD, Sub-Investigator
Rajesh Sehgal, MD, Sub-Investigator
Matthew Sulecki, MD, Sub-Investigator
Franklin Viverette, MD, Sub-Investigator

Arnold Palmer Cancer Center - Oakbrook, Greensburg, Pennsylvania 15601, United States; Recruiting
Diane Trout, Phone: 724-834-1463, Ext: 119, Email: troutdl@upmc.edu
Hyoung Kim, MD, Sub-Investigator
John Waas, DO, Sub-Investigator

UPMC CancerCenter - Greenville, Greenville, Pennsylvania 16125, United States; Recruiting
Kristy Thompson, Phone: 814-676-7881, Email: thompsonk15@upmc.edu
Edgardo Lob, MD, Sub-Investigator

UPMC CancerCenter - Indiana, Indiana, Pennsylvania 15701, United States; Recruiting
Judy Sosko, Phone: 814-534-2887, Email: soskoj@upmc.edu
Gopala Ramineni, MD, Sub-Investigator
Michael Voloshin, MD, Sub-Investigator

UPMC CancerCenter at John P. Murtha Regional Cancer Center, Johnstown, Pennsylvania 15901, United States; Recruiting
Judy Sosko, Phone: 814-533-0106, Email: soskoj@upmc.edu
Rashid Awan, MD, Sub-Investigator
Michael Voloshin, MD, Sub-Investigator

UPMC CancerCenter - Mckeesport, McKeesport, Pennsylvania 15132, United States; Recruiting
Anita Doyle, Phone: 412-653-8103, Email: doylea2@upmc.edu
Jason Bierenbaum, MD, Sub-Investigator
Kevin Kane, MD, Sub-Investigator

UPMC CancerCenter - Monroeville, Monroeville, Pennsylvania 15146, United States; Recruiting
Michelle Zaspel, Phone: 412-374-1441, Email: zaspma@upmc.edu
Hyoung Kim, MD, FACP, Sub-Investigator
John Lech, DO, Sub-Investigator
Dhaval Mehta, MD, Sub-Investigator
John Morcos, MD, Sub-Investigator
Rajesh Sehgal, MD, Sub-Investigator

Arnold Palmer Medical Oncology - Mount Pleasant, Mount Pleasant, Pennsylvania 15666, United States; Recruiting
Diane Trout, Phone: 724-834-1463, Ext: 119, Email: troutdl@upmc.edu
Hyoung Kim, MD, Sub-Investigator
John P Morcos, MD, Sub-Investigator

UPMC CancerCenter - New Castle, New Castle, Pennsylvania 16105, United States; Recruiting
Karen Flanagan, Phone: 724-658-0853, Ext: 107, Email: flanagankd@upmc.edu
Sheryl Simon, MD, Sub-Investigator
William Spielvogel, MD, Sub-Investigator

UPMC CancerCenter - Hillman Cancer Center, Pittsburgh, Pennsylvania 15232, United States; Recruiting
Bethany Flaherty, Phone: 412-623-8962, Email: schnelbachb@upmc.edu
Kristyn Miller, Phone: 412-647-8475, Email: millerkm3@upmc.edu
Leonard J Appleman, MD, PhD, Principal Investigator
Lanie K Francis, MD, Sub-Investigator
David M Friedland, MD, Sub-Investigator
Barry C Lembesky, MD, Sub-Investigator
Stanley M Marks, MD, Sub-Investigator
James P Ohr, DO, Sub-Investigator
Rahul A Parikh, MD, PhD, Sub-Investigator
Daniel P Petro, MD, Sub-Investigator
John C Rhee, MD, Sub-Investigator
Ronald G Stroller, MD, Sub-Investigator

UPMC CancerCenter - Passavant HOA, Pittsburgh, Pennsylvania 15237, United States; Recruiting
Melissa Jackson, Phone: 412-748-6027, Email: jacksonm12@upmc.edu
Jennifer Osborn, MD, Sub-Investigator

UPMC CancerCenter - Passavant OHA, Pittsburgh, Pennsylvania 15237, United States; Recruiting
Melissa Jackson, Phone: 412-748-6027, Email: jacksonm12@upmc.edu
Theodore Crandall, MD, Sub-Investigator
Robert Gluckman, MD, Sub-Investigator
Brian McLaughlin, MD, Sub-Investigator
Kiran Rajasenan, MD, Sub-Investigator

UPMC CancerCenter - St. Margaret, Pittsburgh, Pennsylvania 15215, United States; Recruiting
Cathy Van Every, Phone: 412-781-3744, Email: vaneverycc@upmc.edu
Peter Ellis, MD, Sub-Investigator
Mark Georgiadis, MD, Sub-Investigator
Hongmei Liang, MD, Sub-Investigator
Min Sun, MD, Sub-Investigator

UPMC CancerCenter - Northwest, Seneca, Pennsylvania 16346, United States; Recruiting
Kristy Thompson, Phone: 814-676-7881, Email: thompsonk15@upmc.edu
Cindylou Connell, MD, Sub-Investigator
Donna Puleio, MD, Sub-Investigator

UPMC CancerCenter - Uniontown, Uniontown, Pennsylvania 15401, United States; Recruiting
Harry Strauser, Phone: 724-439-8950, Ext: 126, Email: strauserhj@upmc.edu
Afaq Ahmad, MD, Sub-Investigator
Lijun Dai, MD, Sub-Investigator
Sajid M Peracha, MD, Sub-Investigator

UPMC CancerCenter - Washington, Washington, Pennsylvania 15301, United States; Recruiting
Elizabeth Goddard, Phone: 724-223-3816, Email: goddardea@upmc.edu
Patrick Kane, MD, Sub-Investigator
Nitin Kapoor, DO, Sub-Investigator
Alexis Megaludis, MD, Sub-Investigator

UPMC CancerCenter - Jefferson, West Mifflin, Pennsylvania 15122, United States; Recruiting
Anita Doyle, Phone: 412-653-8103, Email: doylea2@upmc.edu
Martin Earle, MD, Sub-Investigator
Andrew Laman, MD, Sub-Investigator

Additional Information

Starting date: February 2015
Last updated: February 24, 2015

Page last updated: August 23, 2015

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