Observational Study of Docetaxel Exposure in Metastatic Prostate Cancer Patients

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02376296
• Other study ID #: SBI-DTX-004
• Status: Completed
• Start date: February 2015
• Est. completion date: February 10, 2018

Study information

• Verified date: February 2022
• Source: Saladax Biomedical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 10, 2018
• Est. primary completion date: February 10, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

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

Locations

Country	Name	City	State
United States	UPMC CancerCenter - Beaver	Beaver	Pennsylvania
United States	UPMC CancerCenter - Upper St. Clair	Bethel Park	Pennsylvania
United States	UPMC CancerCenter - Horizon	Farrell	Pennsylvania
United States	Arnold Palmer Cancer Center	Greensburg	Pennsylvania
United States	Arnold Palmer Cancer Center - Oakbrook	Greensburg	Pennsylvania
United States	UPMC CancerCenter - Greenville	Greenville	Pennsylvania
United States	UPMC CancerCenter - Indiana	Indiana	Pennsylvania
United States	UPMC CancerCenter at John P. Murtha Regional Cancer Center	Johnstown	Pennsylvania
United States	UPMC CancerCenter - Mckeesport	McKeesport	Pennsylvania
United States	UPMC CancerCenter - Monroeville	Monroeville	Pennsylvania
United States	Arnold Palmer Medical Oncology - Mount Pleasant	Mount Pleasant	Pennsylvania
United States	UPMC CancerCenter - New Castle	New Castle	Pennsylvania
United States	UPMC CancerCenter - Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	UPMC CancerCenter - Passavant HOA	Pittsburgh	Pennsylvania
United States	UPMC CancerCenter - Passavant OHA	Pittsburgh	Pennsylvania
United States	UPMC CancerCenter - St. Margaret	Pittsburgh	Pennsylvania
United States	UPMC CancerCenter - Northwest	Seneca	Pennsylvania
United States	UPMC CancerCenter - Uniontown	Uniontown	Pennsylvania
United States	UPMC CancerCenter - Washington	Washington	Pennsylvania
United States	UPMC CancerCenter - Jefferson	West Mifflin	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Saladax Biomedical, Inc.	UPMC CancerCenter

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Frequency of growth factor usage	Determine relationship (if any) between growth factor usage and docetaxel exposure levels.	Up to 7 months after the initiation of docetaxel therapy
Secondary	Number of days hospitalized for treatment of docetaxel related toxicities	Determine relationship (if any) between number of day hospitalized due to treatment related toxicities and docetaxel exposure levels.	Up to 7 months after the initiation of docetaxel therapy
Secondary	Time to prostate specific antigen (PSA) progression	Determine relationship (if any) between the time to PSA progression and docetaxel exposure levels obtained during the first 6 cycles of treatment.	Up to 24 months after the initiation of docetaxel therapy
Secondary	Tumor response as determined by imaging	Determine relationship (if any) between the tumor response as determined by imaging and docetaxel exposure levels obtained during the first 6 cycles of treatment.	Up to 7 months after the initiation of docetaxel therapy
Secondary	Changes in quality of life	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.	Up to 6 months after the initiation of docetaxel therapy
Secondary	Overall survival	Determine relationship between overall survival and docetaxel exposure levels obtained during the first 6 cycles of treatment.	Up to 24 months after the initiation of docatexel therapy