Clinical Trials /

Phase 2 of Carbo, Taxel and Abi in Metastatic Castration Prostate Cancer

NCT03934840

Description:

This is a phase II clinical trial in patients with metastatic castration sensitive prostate cancer. The objective of the study is to determine the efficacy and further define the safety of the treatment combination. This study will evaluate dose levels of carboplatin AUC 4 with cabazitaxel 20 mg/m2. Patients will be treated with the combination of ADT and carboplatin and cabazitaxel for 6 cycles. After 6 cycles of chemotherapy, they will start abiraterone with ADT. The primary objective is to determine the percent of subjects that have no PSA or radiographic progression at 1 year. Secondary objectives will include determining the progression‐free survival, time to PSA nadir and time to PSA progression of carboplatin and cabazitaxel in combination with ADT.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase 2 of Carbo, Taxel and Abi in Metastatic Castration Prostate Cancer
  • Official Title: A Phase II Study of Carboplatin, Cabazitaxel and Abiraterone in Metastatic Castration Sensitive Prostate Cancer With and Without DNA Repair Mutations

Clinical Trial IDs

  • ORG STUDY ID: 2018LS158
  • NCT ID: NCT03934840

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
CabazitaxelCarboplatin, Cabazitaxel and Abiraterone
CarboplatinCarboplatin, Cabazitaxel and Abiraterone
AbirateroneCarboplatin, Cabazitaxel and Abiraterone
PrednisoneCarboplatin, Cabazitaxel and Abiraterone

Purpose

This is a phase II clinical trial in patients with metastatic castration sensitive prostate cancer. The objective of the study is to determine the efficacy and further define the safety of the treatment combination. This study will evaluate dose levels of carboplatin AUC 4 with cabazitaxel 20 mg/m2. Patients will be treated with the combination of ADT and carboplatin and cabazitaxel for 6 cycles. After 6 cycles of chemotherapy, they will start abiraterone with ADT. The primary objective is to determine the percent of subjects that have no PSA or radiographic progression at 1 year. Secondary objectives will include determining the progression‐free survival, time to PSA nadir and time to PSA progression of carboplatin and cabazitaxel in combination with ADT.

Trial Arms

NameTypeDescriptionInterventions
Carboplatin, Cabazitaxel and AbirateroneExperimental
  • Cabazitaxel
  • Carboplatin
  • Abiraterone
  • Prednisone

Eligibility Criteria

        Inclusion Criteria:

          -  Willing and able to provide, or have a legally authorized representative provide,
             written informed consent and HIPAA authorization for the release of personal health
             information. A signed informed consent must be obtained before screening procedures
             are performed.

          -  Histologically confirmed prostate cancer.

          -  High volume metastatic disease (defined as the presence of visceral metastases or ≥3
             bone lesions).

          -  ADT for ≤3 months by day 1 of study chemotherapy; Prior episodes of ADT are allowed
             (i.e. ADT used previously in courses of radiation).

          -  Testosterone <50 ng/dL. Patients must continue primary ADT with an LHRH analogue if
             they have not undergone orchiectomy.

          -  ECOG Performance Status 0 or 1 (see Appendix A)

          -  Patient has adequate bone marrow and organ function as defined by the following
             laboratory values:

               -  Absolute neutrophil count ≥ 1.5 × 109

                  /L.

               -  Platelets ≥ 100 × 109

                  /L.

               -  Hemoglobin ≥ 9 g/dl.

               -  Serum creatinine ≤ 1.5mg/dL or estimated creatinine clearance ≥ 50 ml/min

               -  In the absence of liver metastases, alanine aminotransferase (ALT) and aspartate
                  aminotransferase (AST) <2.5 x ULN. If the patient has liver metastases, ALT and
                  AST <5 x ULN

               -  Total bilirubin < ULN; or total bilirubin ≤3.0 x ULN or direct bilirubin ≤1.5 x
                  ULN in patients with well‐documented Gilbert's Syndrome.

          -  Sexually active males must use a condom during intercourse while taking study drugs
             and for 30 days after stopping treatment and should not father a child in this period.
             A condom is required to be used also by vasectomized men in order to prevent delivery
             of the drug via seminal fluid. Fertile males must use a condom with spermicide (double
             barrier method).

          -  Age ≥ 18 years

        Exclusion Criteria:

          -  Prior exposure to any chemotherapy, PARPi, or immunotherapy for prostate cancer.

          -  Prior abiraterone or enzalutamide, unless therapy was for < 2 weeks

          -  Radiation therapy (including palliative radiotherapy to a metastatic lesion) within 14
             days or major surgery (e.g., open abdominal, pelvic, thoracic, orthopedic or
             neurosurgery) within 28 days of the date of the first dose.

          -  Other systemic therapies for prostate cancer within 28 days or 5 half‐lives, whichever
             is shorter, prior to day 1 of chemotherapy (with the exception of anti‐androgens like
             bicalutamide).

          -  PSA <2.0 ng/mL at diagnosis.

          -  If present, peripheral neuropathy must be ≤ Grade 1

          -  Patients with an active second malignancy that could, in the investigator's opinion,
             potentially interfere with the patient's ability to participate and/or complete this
             trial.

          -  Patients with central nervous system (CNS) involvement unless they meet ALL of the
             following criteria:

               -  At least 4 weeks from prior therapy completion (including radiation and/or
                  surgery) prior to starting the study treatment

               -  Clinically stable CNS tumor at the time of screening.

               -  Baseline screening for CNS metastases is not required unless presence of signs
                  and/or symptoms of involvement

          -  Patients with severe psychiatric illness/social situations that would limit compliance
             with study requirements in the judgment of treating investigator.

          -  Patient has a history of non‐compliance to medical regimen or inability to grant
             consent.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Prostate-Specific Antigen (PSA) or Radiographic Progression
Time Frame:1 Year
Safety Issue:
Description:Proportion of patients who have no PSA or radiographic progression as determined by RECIST 1.1 or PCWG3 criteria

Secondary Outcome Measures

Measure:Progression‐Free Survival (PFS)
Time Frame:1 Year
Safety Issue:
Description:Incidence of PFS
Measure:PSA Nadir
Time Frame:1 Year
Safety Issue:
Description:Time to time to PSA nadir
Measure:Incidence of adverse events
Time Frame:1 Year
Safety Issue:
Description:Safety and Tolerability
Measure:Incidence of Homologous Recombination Deficiency (HRD)
Time Frame:1 Year
Safety Issue:
Description:Incidence of HRD
Measure:PSA Complete Response Rate
Time Frame:1 Year
Safety Issue:
Description:PSA complete response rate (PSA <0.2 ng/ml) in patient with mutations in DNA repair genes
Measure:PSA Complete Response Rate
Time Frame:1 Year
Safety Issue:
Description:PSA complete response rate (PSA <0.2 ng/ml) in patient without mutations in DNA repair genes
Measure:PSA Progression
Time Frame:1 Year
Safety Issue:
Description:Time to PSA progression

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Masonic Cancer Center, University of Minnesota

Last Updated

November 11, 2019