Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02985021
Other study ID # PugetSoundVA
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date November 2016
Est. completion date April 2021

Study information

Verified date August 2021
Source Seattle Institute for Biomedical and Clinical Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This is a phase 2 study of the combination of docetaxel and carboplatin in patients with germline inactivation of genes in the homologous recombination pathway, including BRCA1, BRCA2, and Ataxia Telangiectasia Mutated (ATM). PRIMARY OBJECTIVE To assess rate of 50% Prostate Specific Androgen (PSA) decline to docetaxel and carboplatin


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date April 2021
Est. primary completion date April 2021
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria Patients meeting the following inclusion criteria will be eligible to participate in this study: 1. 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. 2. Age > 18 years 3. Known prostate cancer 4. 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. 5. 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. 6. Prior therapy with abiraterone acetate, enzalutamide, or docetaxel. There is no limit to the number of prior treatment regimens. 7. Presence of metastatic disease on scans. 8. Eastern Cooperative Oncology Group (ECOG) Performance Status of = 2. 9. Life expectancy >12 weeks. 10. 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). 11. Patients must have adequate organ and marrow function as defined below obtained within 14 days prior to start of therapy: 1. Absolute neutrophil count >1.5 x 109 cells/L 2. Hgb > 9.0 g/dL 3. Platelets >100,000 x 109/L 4. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin levels < 1.5 x Upper Limit of Normal (ULN) 12. Presence of germline inactivation of BRCA1, BRCA2, ATM OR one of the following: - Patients with clearly deleterious germline mutations of other genes involved in homologous DNA repair may be included at the investigator's discretion. - Patients with homozygous inactivation of genes involved in homologous recombination from primary or metastatic tumor as assessed by a Clinical Laboratory Improvement Amendments (CLIA) level assay for DNA sequencing may be included. - Patients with a signature of homologous recombination deficiency in primary or metastatic tissue may be included (VA Puget Sound only). Exclusion Criteria Patients who meet any of the following criteria will be excluded from the study: 1. Currently receiving active therapy for other neoplastic disorders. 2. Histologic evidence of small cell carcinoma (morphology alone - immunohistochemical evidence of neuroendocrine differentiation without morphologic evidence is not exclusionary). 3. Prior treatment with platinum-based chemotherapy for prostate cancer. 4. Known parenchymal brain metastasis. 5. Active or symptomatic viral hepatitis or chronic liver disease. 6. 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. 7. Treatment with an investigational therapeutic within 30 days of Cycle 1. 8. Patients with dementia/psychiatric illness/social situations limiting compliance with study requirements or understanding and/or giving of informed consent are not eligible 9. 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.

Study Design


Intervention

Drug:
Carboplatin
Chemotherapy
Docetaxel
Chemotherapy

Locations

Country Name City State
United States VA Ann Arbor Health Care System Ann Arbor Michigan
United States VA Greater Los Angeles - West LA Los Angeles California
United States VA Puget Sound Health Care System Seattle Washington

Sponsors (3)

Lead Sponsor Collaborator
Seattle Institute for Biomedical and Clinical Research Prostate Cancer Foundation, VA Puget Sound Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
See also
  Status Clinical Trial Phase
Terminated NCT02491411 - Dexamethasone Prior to Re-treatment With Enzalutamide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Previously Treated With Enzalutamide and Docetaxel N/A
Active, not recruiting NCT01685125 - Abiraterone Acetate and Prednisone With or Without Dasatinib in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Phase 2
Completed NCT00936975 - Fluorine F 18 Sodium Fluoride Positron Emission Tomography in Evaluating Response to Dasatinib in Patients With Prostate Cancer and Bone Metastases Phase 2
Completed NCT00087139 - Ixabepilone in Treating Patients With Metastatic Prostate Cancer Phase 2
Active, not recruiting NCT03511196 - Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer Early Phase 1
Completed NCT01881867 - CYT107 After Vaccine Treatment (Provenge®) in Patients With Metastatic Castration-Resistant Prostate Cancer Phase 2
Completed NCT01385059 - Axitinib Before Surgery in Treating Patients With High-Risk Prostate Cancer Phase 2
Terminated NCT01866423 - Orteronel in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Phase 2
Active, not recruiting NCT02807805 - Abiraterone Acetate, Niclosamide, and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer Phase 2
Completed NCT01468532 - Docetaxel, Prednisone, and Pasireotide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Phase 1/Phase 2
Completed NCT01026623 - Cixutumumab and Temsirolimus in Treating Patients With Metastatic Prostate Cancer Phase 1/Phase 2
Completed NCT01682941 - Soy Isoflavones in Treating Patients With Recurrent Prostate Cancer or Rising Prostate-Specific Antigen N/A
Terminated NCT00536991 - Calcitriol in Combination With Ketoconazole and Therapeutic Hydrocortisone in Treating Patients With Prostate Cancer Phase 1/Phase 2
Completed NCT00074022 - GTI-2040 and Docetaxel in Treating Patients With Recurrent, Metastatic, or Unresectable Locally Advanced Non-Small Cell Lung Cancer, Prostate Cancer, or Other Solid Tumors Phase 1/Phase 2
Completed NCT03707184 - Fluciclovine F18 PET/CT Imaging in Assessing Hormone-Naive Men With Prostate Cancer That Has Spread to the Bone Phase 2
Withdrawn NCT00003534 - Antineoplaston Therapy in Treating Patients With Refractory Stage IV Prostate Cancer Phase 2
Recruiting NCT04113096 - Dibenzyl Trisulphide (GUINEAHEN WEED) for Stage IV Cancer Early Phase 1
Active, not recruiting NCT03344211 - Enzalutamide With or Without Radium Ra 223 Dichloride in Patients With Metastatic, Castration-Resistant Prostate Cancer Phase 2
Recruiting NCT02615223 - Endocrine Therapy With or Without Cryoablation for Stage IV Prostate Cancer N/A
Terminated NCT00527124 - Docetaxel and Prednisone With or Without Cediranib in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy Phase 2