Docetaxel and Carboplatin for Patients With mCRPC and DNA-Repair Deficiencies

NCT02985021 | Terminated Phase 2 Results DMC

• 1 other identifier: PugetSoundVA
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 3

Brief Summary

In this study, patients who have metastatic prostate cancer that does not respond to hormone treatment and who have mutations in certain cancer-related genes will be treated with docetaxel and carboplatin chemotherapy.

Conditions

Hormone-Resistant Prostate Cancer; Metastatic Prostate Carcinoma; Recurrent Prostate Carcinoma; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Achieving >= 50% Reduction in PSA According to Prostate Cancer Working Group 3 (PCWG3) Criteria

  Achievement of a PSA50 decline is whether the treatment results in a 50% or greater decline in PSA from baseline PSA prior to therapy

  From Day 1 of treatment and up to 30 days after completion of treatment (typically up to 10 cycles of chemotherapy)

Study Arms (1)

Treatment (docetaxel, carboplatin)

EXPERIMENTAL

Docetaxel 60 mg/m2 will be administered on Day 1 of each 21-day cycle. Carboplatin Area Under the Curve (AUC) 5 will be administered on Day 1 of each 21-day cycle. Docetaxel and carboplatin should be administered per institutional guidelines. Treatment will be repeated until disease progression or unacceptable toxicity.

Drug: Carboplatin; Drug: Docetaxel

Interventions

Carboplatin DRUG

Chemotherapy

Also known as: Paraplatin

Treatment (docetaxel, carboplatin)

Docetaxel DRUG

Chemotherapy

Also known as: Taxotere

Treatment (docetaxel, carboplatin)

Eligibility Criteria

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

You may qualify if:

• 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.
• Age \> 18 years
• Known prostate cancer
• 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 serum testosterone \< 50ng/ml 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 acetate, enzalutamide, 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 ≤ 2.
• 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

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from the study:
• Currently receiving active therapy for other neoplastic disorders.
• Prior treatment with platinum-based chemotherapy for prostate cancer.
• 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.

Sponsors & Collaborators

• Seattle Institute for Biomedical and Clinical Research: lead
• Prostate Cancer Foundation: collaborator
• VA Puget Sound Health Care System: collaborator

Study Sites (3)

VA Greater Los Angeles - West LA

Los Angeles, California, 90073, United States

Location

VA Ann Arbor Health Care System

Ann Arbor, Michigan, 48105, United States

Location

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Carboplatin; Docetaxel

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)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: Dr. Bruce Montgomery, PI
• Organization: VA Puget Sound HCS

rbmontgo@uw.edu

2062776878

Study Officials

• Robert B Montgomery, MD

  VA Puget Sound HCS

  PRINCIPAL INVESTIGATOR

• Matthew Rettig, MD

  VA Greater Los Angeles HCS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: December 7, 2016
• Study Start: November 1, 2016
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: August 5, 2021
• Results First Posted: August 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)