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NCT02598895

Docetaxel and Carboplatin in Treating Patients With Metastatic, Castration Resistant Prostate Cancer Containing Inactivated Genes in the BRCA 1/2 Pathway

Completed Phase 2 Results posted Last updated 17 November 2022
What this trial tests

Phase 2 trial testing Carboplatin in Castration Levels of Testosterone in 14 participants. Completed in 14 September 2021.

Timeline
26 January 2016
Primary endpoint
14 September 2021
14 September 2021

Quick facts

Lead sponsorUniversity of Washington
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment14
Start date26 January 2016
Primary completion14 September 2021
Estimated completion14 September 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Washington

Who can join

18 and older, male only, with Castration Levels of Testosterone or Castration-Resistant Prostate Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Patients With PSA Decline by 50% From Baseline Primary · 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 50% from baseline according to Prostate Cancer Working Group 2 (PCWG2) criteria

GroupValue95% CI
Treatment (Docetaxel, Carboplatin)9
Treatment (Docetaxel, Carboplatin)5

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events data were collected up to 2.5 years after the last dose of study treatment for each participant.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (Docetaxel, Carboplatin)
Serious: 0/14 (0%)
Deaths: 10/14
Other adverse events (7 terms — click to expand)

ReactionSystemTreatment (Docetaxel, Carb…
Platelet Count DecreasedBlood and lymphatic system disorders
AnemiaBlood and lymphatic system disorders
Neutrophil Count DecreasedBlood and lymphatic system disorders
Maculopapular rashSkin and subcutaneous tissue disorders
Disseminated Intravascular CoagulationBlood and lymphatic system disorders
AnaphylaxisImmune system disorders
LeukocytosisBlood and lymphatic system disorders

Data from ClinicalTrials.gov NCT02598895 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Genetic aberrations in DNA repair pathways: a cornerstone of precision oncology in prostate cancer.
    Lozano R, Castro E, Aragón IM, Cendón Y, et al · · 2021 · cited 81× · PMID 33106584 · DOI 10.1038/s41416-020-01114-x
  2. Role of the DNA damage response in prostate cancer formation, progression and treatment.
    Zhang W, van Gent DC, Incrocci L, van Weerden WM, et al · · 2020 · cited 58× · PMID 31197228 · DOI 10.1038/s41391-019-0153-2
  3. DNA Damage Response in Prostate Cancer.
    Schiewer MJ, Knudsen KE. · · 2019 · cited 44× · PMID 29530944 · DOI 10.1101/cshperspect.a030486
  4. Impact of DNA damage repair defects and aggressive variant features on response to carboplatin-based chemotherapy in metastatic castration-resistant prostate cancer.
    Slootbeek PHJ, Duizer ML, van der Doelen MJ, Kloots ISH, et al · · 2021 · cited 30× · PMID 32965028 · DOI 10.1002/ijc.33306
  5. Polyclonal <i>BRCA2</i> Reversion Mutations Detected in Circulating Tumor DNA After Platinum Chemotherapy in a Patient With Metastatic Prostate Cancer.
    Cheng HH, Salipante SJ, Nelson PS, Montgomery B, et al · · 2018 · cited 25× · PMID 32913984 · DOI 10.1200/po.17.00169
  6. Treatment strategies for DNA repair-deficient prostate cancer.
    Teply BA, Antonarakis ES. · · 2017 · cited 25× · PMID 28573914 · DOI 10.1080/17512433.2017.1338138
  7. A Pilot Study of Clinical Targeted Next Generation Sequencing for Prostate Cancer: Consequences for Treatment and Genetic Counseling.
    Cheng HH, Klemfuss N, Montgomery B, Higano CS, et al · · 2016 · cited 25× · PMID 27324988 · DOI 10.1002/pros.23219
  8. Pharmacogenomic Biomarkers in Docetaxel Treatment of Prostate Cancer: From Discovery to Implementation.
    Varnai R, Koskinen LM, Mäntylä LE, Szabo I, et al · · 2019 · cited 17× · PMID 31398933 · DOI 10.3390/genes10080599

Verify or expand the search:

Other trials of Carboplatin

Trials testing the same drug.

Other recruiting trials for Castration Levels of Testosterone

Currently open trials in the same condition.

Other University of Washington trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing