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Trial record 1 of 1 for:    NCT02598895
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Docetaxel and Carboplatin in Treating Patients With Metastatic, Castration Resistant Prostate Cancer Containing Inactivated Genes in the BRCA 1/2 Pathway

This study is currently recruiting participants.
Verified November 2017 by University of Washington
Sponsor:
ClinicalTrials.gov Identifier:
NCT02598895
First Posted: November 6, 2015
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington
  Purpose
This pilot clinical trial studies docetaxel and carboplatin in treating patients with castration resistant prostate cancer that has spread from the primary site (place where it started) to other places in the body (metastatic) and contains inactivated genes in the BRCA 1/2 pathway. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Condition Intervention
Castration Levels of Testosterone Castration-Resistant Prostate Carcinoma Metastatic Prostate Carcinoma Prostate Carcinoma Metastatic in the Bone PSA Progression Stage IV Prostate Cancer Drug: Carboplatin Drug: Docetaxel Other: Laboratory Biomarker Analysis

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Docetaxel and Carboplatin for Treatment of Patients With Metastatic, Castration Resistant Prostate Cancer Containing Biallelic Inactivation of Genes in the BRCA1/2 Pathway

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Proportion of patients with PSA decline by 50% from baseline according to Prostate Cancer Working Group 2 (PCWG2) criteria [ Time Frame: Until disease progression or unacceptable toxicity, assessed up to 35 days after the last dose of study medication ]

Secondary Outcome Measures:
  • Median time to disease progression (Prostate Cancer Working Group 2 [PCWG2] criteria) [ Time Frame: Until disease progression or unacceptable toxicity, assessed up to 35 days after the last dose of study medication ]
  • Number of patients with deoxyribonucleic acid (DNA) repair pathway mutations in circulating tumor cell (CTC) and cell free DNA [ Time Frame: Baseline ]
  • Proportion of patients achieving 30% reduction in measurable disease from baseline, according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Until disease progression or unacceptable toxicity, assessed up to 35 days after the last dose of study medication ]
  • Proportion of patients with PSA decline by 90% from baseline (Prostate Cancer Working Group 2 [PCWG2] criteria) [ Time Frame: Until disease progression or unacceptable toxicity, assessed up to 35 days after the last dose of study medication ]
  • Time to progression of bone lesions or measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [ Time Frame: Until disease progression or unacceptable toxicity, assessed up to 35 days after the last dose of study medication ]

Estimated Enrollment: 14
Actual Study Start Date: January 26, 2016
Estimated Primary Completion Date: June 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (docetaxel, carboplatin)
Patients receive docetaxel IV over 30-60 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 10 courses in the absence of disease progression or unacceptable toxicity.
Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo
Drug: Docetaxel
Given IV
Other Names:
  • Docecad
  • RP56976
  • Taxotere
  • Taxotere Injection Concentrate
Other: Laboratory Biomarker Analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess rate of 50% prostate-specific antigen (PSA) decline to docetaxel and carboplatin.

SECONDARY OBJECTIVES:

I. To assess PSA response duration to docetaxel and carboplatin. (Phase 2)

II. To assess response of measurable disease. (Phase 2)

III. To assess time to progression of bone lesions or measurable disease (Response Evaluation Criteria in Solid Tumors [RECIST]). (Phase 2)

IV. To assess response to docetaxel and carboplatin in tumors with mutation of deoxyribonucleic acid (DNA) repair pathway genes (breast cancer [BRCA]1, BRCA2, ataxia telangiectasia mutated [ATM]). (Phase 2)

V. To correlate the presence of DNA repair pathway mutations and copy number alterations in metastatic tissue versus in circulating tumor cells (CTC) and cell free DNA. (Phase 2)

VI. To correlate changes in CTC number with PSA and radiographic response. (Phase 2)

OUTLINE:

Patients receive docetaxel intravenously (IV) over 30-60 minutes and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 10 courses in the absence of disease progression or unacceptable toxicity.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and release of health and research trial information
  • Histologically or cytologically confirmed carcinoma of the prostate (excluding neuroendocrine differentiation or squamous cell histology)
  • Ongoing gonadal androgen deprivation therapy with gonadotropin-releasing hormone (GnRH) analogues, antagonists or orchiectomy; patients who have not had an orchiectomy must be maintained on effective GnRH analogue/antagonist therapy
  • Castration resistant prostate cancer as defined by rising PSA when serum testosterone < 50 ng/ml (note: current testosterone results are not required if the potential subject has not missed any GnRH analogue/antagonist doses since their last result was received) AND one of the following:

    • PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions at least 1 week apart
    • Evaluable disease progression by modified RECIST (Response Evaluation Criteria in Solid Tumors)
    • Progression of metastatic bone disease on bone scan with > 2 new lesions
  • Prior therapy with abiraterone, enzalutamide and/or docetaxel; there is no limit to the number of prior treatment regimens
  • Presence of metastatic disease on scans
  • Eastern Cooperative Oncology Group (ECOG) performance status of =< 1
  • Life expectancy >= 12 weeks
  • No prior malignancy is allowed except:

    • Adequately treated basal cell or squamous cell skin cancer or
    • In situ carcinoma of any site or
    • Other adequately treated malignancy for which the patient has been disease-free for at least one year (any prior chemotherapy is allowed)
  • Absolute neutrophil count >= 1.5 x 10^9 cells/L
  • Hemoglobin (Hgb) >= 9.0 g/dL
  • Platelets >= 100,000 x 10^9/L
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 1.5 x upper limit of normal (ULN)
  • Total bilirubin levels =< 1.5 x ULN
  • Patients must have clear and documented evidence of biallelic inactivation BRCA1, BRCA2 or ATM by sequencing, for example University of Washington (UW)-Oncoplex, SU2C, or Foundation One testing and/or patients with clearly deleterious mutations of other genes involved in homologous DNA repair (e.g., partner and localizer of BRCA2 [PALB2], BRCA1-interacting protein 1 [BRIP1], etc.) by sequencing via UW-Oncoplex, SU2C, or Foundation One testing may be included at the investigator's discretion

Exclusion Criteria:

  • Currently receiving active therapy for other neoplastic disorders
  • Histologic evidence of neuroendocrine or small cell carcinoma of the prostate
  • Known parenchymal brain metastasis
  • Active or symptomatic viral hepatitis or chronic liver disease
  • Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) class II-IV heart disease or cardiac ejection fraction measurement of < 35 % at baseline, if done
  • Treatment with an investigational therapeutic within 30 days of cycle 1
  • Patients with dementia/psychiatric illness/social situations limiting compliance with study requirements or understanding and/or giving of informed consent are not eligible
  • Any medical conditions, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained are not eligible
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02598895


Locations
United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Heather H. Cheng    206-606-1406    hhcheng@u.washington.edu   
Principal Investigator: Heather H. Cheng         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
Principal Investigator: Heather Cheng Fred Hutch/University of Washington Cancer Consortium
  More Information

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT02598895     History of Changes
Other Study ID Numbers: 9381
NCI-2015-01694 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
9381 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
P50CA097186 ( U.S. NIH Grant/Contract )
First Submitted: October 13, 2015
First Posted: November 6, 2015
Last Update Posted: November 6, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Carcinoma
Prostatic Neoplasms
Disease Progression
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Disease Attributes
Pathologic Processes
Docetaxel
Carboplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action