Clinical trial NCT02311764: Carboplatin in Castration-resistant Prostate Cancer
Official title: Single Arm Open Label Phase II Pilot Study of Carboplatin in Patients With Metastatic Castrationresistant Prostate Cancer (CRPC) and PTEN Loss and/or DNA Repair Defects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostatic Neoplasm
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
Collaborators: name: Teva Pharma
name: University Hospital, Zürich
First posted: 2014-12-08
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open label, non-randomised phase II clinical pilot study

Detailed description: Pilot Study of weekly Carboplatin in Patients with Advanced Metastatic Castration-Resistant Prostate Cancer (CRPC) and DNA repair defects

Eligibility criteria: Inclusion Criteria:

1. Written Informed Consent
2. Adult patients with histological diagnosis of adenocarcinoma of the prostate.
3. Metastatic Castration-Resistant Prostate Cancer (mCRPC)
4. Progression after at least one taxane-based chemotherapy (or contraindication against taxanes) and at least one therapy with a newer hormonal agent (Cyp17 inhibitor or a new generation AA like enzalutamide).
5. DNA repair defects as per central assessment
6. Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0 - 2
7. Progression of disease by any of the criteria listed here:

   * PSA utilizing PCWG 2 criteria
   * Bone scan
   * RECIST 1.1
8. Adequate organ and bone marrow function as evidenced by:

   * Haemoglobin ≥8.0 g/dL
   * Absolute neutrophil count ≥1.5 x 109/L
   * Platelet count ≥ 100 x 109/L
   * AST and/or ALT \< 2.5 x ULN, in the presence of liver metastases: AST ≥5 x ULN, ALT \<5 x ULN
   * Total bilirubin \< 2.0 x ULN (except for patients with Gilbert's disease)
   * Creatinine Clearance ≥30ml/min
9. Patient must agree in the biomarker studies including the fresh tumour biopsies

Exclusion Criteria:

1. Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product Carboplatin
2. Prior treatment with any prior platinum based chemotherapy,
3. Major surgery within 4 weeks prior to planned start of treatment
4. Known brain or leptomeningeal involvement unless clinically stable and on stable dose of steroids
5. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
6. Previous enrolment into the current study
7. Active secondary malignancy that requires systemic therapy.

Primary outcomes:
measure: Response
timeFrame: Time Frame: Up to the end of the treatment phase (ie, approximately 6 months
Secondary outcomes:
measure: Rate of PSA declines of ≥30%
timeFrame: Time Frame: At 12 weeks and up to the end of the treatment phase (ie, approximately 6 months)
measure: OS
timeFrame: Time Frame: livelong follow-up
measure: rPFS
timeFrame: Time Frame: Up to the end of the treatment phase (ie, approximately 6 months
measure: PSA
timeFrame: on studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months
measure: Safety as per CTC AEv4.03
timeFrame: on studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months
measure: Disease control rate
timeFrame: On studyTime Frame: Up to the end of the treatment phase (ie, approximately 6 months
measure: PTEN loss
timeFrame: Pre-study biopsy sample
Other outcomes:
Locations:
city: Chur
country: Switzerland
facility: Cantonal Hospital Chur
state: Graubuenden
city: Luzern
country: Switzerland
facility: Luzern Cantonal Hospital
city: St.Gallen
country: Switzerland
facility: Cantonal Hospital St.Gallen
Study officials:
affiliation: Cantonal Hospital St. Gallen
name: Aurelius G Omlin, MD
role: PRINCIPAL_INVESTIGATOR
References: