Observational Study of Docetaxel Exposure in Metastatic Prostate Cancer Patients

NCT02376296 | Completed

• 1 other identifier: SBI-DTX-004
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Prostate Cancer

Keywords

metastatic prostate cancer; castrate resistant prostate cancer; CRPC; hormone sensitive prostate cancer

Outcome Measures

Primary Outcomes (2)

• Variability of docetaxel exposure

  Blood will be drawn during the first six cycles of docetaxel therapy to determine the variability of docetaxel exposure.

  Up to 6 months after the initiation of docetaxel therapy

• Docetaxel treatment related toxicities

  Determine the relationship between docetaxel plasma concentrations (i.e. exposure level) and the incidence of docetaxel related toxicities for identification of an optimal target docetaxel exposure range.

  Up to 7 months after the initiation of docetaxel therapy

Secondary Outcomes (6)

• Frequency of growth factor usage

  Up to 7 months after the initiation of docetaxel therapy

• Number of days hospitalized for treatment of docetaxel related toxicities

  Up to 7 months after the initiation of docetaxel therapy

• Time to prostate specific antigen (PSA) progression

  Up to 24 months after the initiation of docetaxel therapy

• Tumor response as determined by imaging

  Up to 7 months after the initiation of docetaxel therapy

• Changes in quality of life

  Up to 6 months after the initiation of docetaxel therapy

Study Arms (2)

hormone naïve

Subjects with hormone naïve metastatic prostate cancer that have high-volume disease and have been on androgen deprivation therapy for less than 120 days prior to starting docetaxel therapy.

Drug: docetaxel; Other: Blood draws

castrate resistant

Subjects with castrate resistant prostate cancer (CRPC) \[defined as having evidence of prostate specific antigen (PSA) progression despite androgen deprivation therapy\] that have had at least four weeks elapse between the withdrawal of anti-androgens (Bicalutamide, Flutamide or Nilutamide) and the initiation of docetaxel therapy.

Drug: docetaxel; Other: Blood draws

Interventions

docetaxel DRUG

3-weekly docetaxel therapy (starting dose of 75 mg/m2)

Also known as: Taxotere

castrate resistant; hormone naïve

Blood draws OTHER

Blood draws for determination of docetaxel plasma levels and exposure (AUC)

castrate resistant; hormone naïve

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Metastatic prostate cancer patients, either newly diagnosed or castrate resistant, who are about to start treatment with a 3-weekly docetaxel treatment regimen (starting dose of 75 mg/m2) within the University of Pittsburgh Medical Center (UPMC) Cancer Center network.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saladax Biomedical, Inc.: lead
• UPMC CancerCenter: collaborator

Study Sites (20)

UPMC CancerCenter - Beaver

Beaver, Pennsylvania, 15009, United States

Location

UPMC CancerCenter - Upper St. Clair

Bethel Park, Pennsylvania, 15102, United States

Location

UPMC CancerCenter - Horizon

Farrell, Pennsylvania, 16121, United States

Location

Arnold Palmer Cancer Center - Oakbrook

Greensburg, Pennsylvania, 15601, United States

Location

Arnold Palmer Cancer Center

Greensburg, Pennsylvania, 15601, United States

Location

UPMC CancerCenter - Greenville

Greenville, Pennsylvania, 16125, United States

Location

UPMC CancerCenter - Indiana

Indiana, Pennsylvania, 15701, United States

Location

UPMC CancerCenter at John P. Murtha Regional Cancer Center

Johnstown, Pennsylvania, 15901, United States

Location

UPMC CancerCenter - Mckeesport

McKeesport, Pennsylvania, 15132, United States

Location

UPMC CancerCenter - Monroeville

Monroeville, Pennsylvania, 15146, United States

Location

Arnold Palmer Medical Oncology - Mount Pleasant

Mount Pleasant, Pennsylvania, 15666, United States

Location

UPMC CancerCenter - New Castle

New Castle, Pennsylvania, 16105, United States

Location

UPMC CancerCenter - St. Margaret

Pittsburgh, Pennsylvania, 15215, United States

Location

UPMC CancerCenter - Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

UPMC CancerCenter - Passavant HOA

Pittsburgh, Pennsylvania, 15237, United States

Location

UPMC CancerCenter - Passavant OHA

Pittsburgh, Pennsylvania, 15237, United States

Location

UPMC CancerCenter - Northwest

Seneca, Pennsylvania, 16346, United States

Location

UPMC CancerCenter - Uniontown

Uniontown, Pennsylvania, 15401, United States

Location

UPMC CancerCenter - Washington

Washington, Pennsylvania, 15301, United States

Location

UPMC CancerCenter - Jefferson

West Mifflin, Pennsylvania, 15122, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Rahul A Parikh, MD, PhD

  UPMC CancerCenter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: March 3, 2015
• Study Start: February 1, 2015
• Primary Completion: February 10, 2018
• Study Completion: February 10, 2018
• Last Updated: February 17, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)