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Observational Study of Docetaxel Exposure in Metastatic Prostate Cancer Patients

Sponsor
Saladax Biomedical, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02376296
Collaborator
UPMC CancerCenter (Other)
35
Enrollment
20
Locations
36.3
Duration (Months)
1.8
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
35 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Observational Study of Metastatic Prostate Cancer Subjects Receiving Docetaxel Therapy for Evaluation of Docetaxel Plasma Levels Using the MyDocetaxel Assay
Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Feb 10, 2018
Actual Study Completion Date :
Feb 10, 2018

Arms and Interventions

Arm Intervention/Treatment
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
3-weekly docetaxel therapy (starting dose of 75 mg/m2)
Other Names:
  • Taxotere

    • Other: Blood draws
    Blood draws for determination of docetaxel plasma levels and exposure (AUC)
    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
    3-weekly docetaxel therapy (starting dose of 75 mg/m2)
    Other Names:
  • Taxotere

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

    Outcome Measures

    Primary Outcome Measures

    1. Variability of docetaxel exposure [Up to 6 months after the initiation of docetaxel therapy]

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

    2. Docetaxel treatment related toxicities [Up to 7 months after the initiation of docetaxel therapy]

      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.

    Secondary Outcome Measures

    1. Frequency of growth factor usage [Up to 7 months after the initiation of docetaxel therapy]

      Determine relationship (if any) between growth factor usage and docetaxel exposure levels.

    2. Number of days hospitalized for treatment of docetaxel related toxicities [Up to 7 months after the initiation of docetaxel therapy]

      Determine relationship (if any) between number of day hospitalized due to treatment related toxicities and docetaxel exposure levels.

    3. Time to prostate specific antigen (PSA) progression [Up to 24 months after the initiation of docetaxel therapy]

      Determine relationship (if any) between the time to PSA progression and docetaxel exposure levels obtained during the first 6 cycles of treatment.

    4. Tumor response as determined by imaging [Up to 7 months after the initiation of docetaxel therapy]

      Determine relationship (if any) between the tumor response as determined by imaging and docetaxel exposure levels obtained during the first 6 cycles of treatment.

    5. Changes in quality of life [Up to 6 months after the initiation of docetaxel therapy]

      Determine relationship between changes in the quality of life (as measured using the FACT-P Questionnaire) and docetaxel exposure levels obtained during the first 6 cycles of treatment.

    6. Overall survival [Up to 24 months after the initiation of docatexel therapy]

      Determine relationship between overall survival and docetaxel exposure levels obtained during the first 6 cycles of treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UPMC CancerCenter - Beaver Beaver Pennsylvania United States 15009
    2 UPMC CancerCenter - Upper St. Clair Bethel Park Pennsylvania United States 15102
    3 UPMC CancerCenter - Horizon Farrell Pennsylvania United States 16121
    4 Arnold Palmer Cancer Center - Oakbrook Greensburg Pennsylvania United States 15601
    5 Arnold Palmer Cancer Center Greensburg Pennsylvania United States 15601
    6 UPMC CancerCenter - Greenville Greenville Pennsylvania United States 16125
    7 UPMC CancerCenter - Indiana Indiana Pennsylvania United States 15701
    8 UPMC CancerCenter at John P. Murtha Regional Cancer Center Johnstown Pennsylvania United States 15901
    9 UPMC CancerCenter - Mckeesport McKeesport Pennsylvania United States 15132
    10 UPMC CancerCenter - Monroeville Monroeville Pennsylvania United States 15146
    11 Arnold Palmer Medical Oncology - Mount Pleasant Mount Pleasant Pennsylvania United States 15666
    12 UPMC CancerCenter - New Castle New Castle Pennsylvania United States 16105
    13 UPMC CancerCenter - St. Margaret Pittsburgh Pennsylvania United States 15215
    14 UPMC CancerCenter - Hillman Cancer Center Pittsburgh Pennsylvania United States 15232
    15 UPMC CancerCenter - Passavant HOA Pittsburgh Pennsylvania United States 15237
    16 UPMC CancerCenter - Passavant OHA Pittsburgh Pennsylvania United States 15237
    17 UPMC CancerCenter - Northwest Seneca Pennsylvania United States 16346
    18 UPMC CancerCenter - Uniontown Uniontown Pennsylvania United States 15401
    19 UPMC CancerCenter - Washington Washington Pennsylvania United States 15301
    20 UPMC CancerCenter - Jefferson West Mifflin Pennsylvania United States 15122

    Sponsors and Collaborators

    • Saladax Biomedical, Inc.
    • UPMC CancerCenter

    Investigators

    • Principal Investigator: Rahul A Parikh, MD, PhD, UPMC CancerCenter

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Saladax Biomedical, Inc.
    ClinicalTrials.gov Identifier:
    NCT02376296
    Other Study ID Numbers:
    • SBI-DTX-004
    First Posted:
    Mar 3, 2015
    Last Update Posted:
    Feb 17, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Saladax Biomedical, Inc.
    metastatic prostate cancer
    castrate resistant prostate cancer
    CRPC
    hormone sensitive prostate cancer
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Docetaxel

    Study Results

    No Results Posted as of Feb 17, 2022