Carboplatin, Everolimus, and Prednisone in Treating Patients With Metastatic Prostate Cancer That Progressed After Docetaxel
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as carboplatin and prednisone, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth and by blocking blood flow to the tumor. Giving carboplatin together
      with everolimus and prednisone may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving carboplatin together with everolimus
      and prednisone works in treating patients with metastatic prostate cancer that progressed
      after docetaxel.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To evaluate the time to progression (TTP) achieved with carboplatin and everolimus in
           patients with castrate resistant metastatic prostate cancer that progressed after
           docetaxel-based chemotherapy.

      Secondary

        -  To evaluate the safety of this regimen.

        -  To assess the PSA response rate in patients treated with this regimen.

        -  To evaluate the overall survival (OS) outcome in these patients.

        -  To investigate the association of TTP and PSA response rate with correlative markers,
           such as phospho mTOR, pAKT, and p70S6.

        -  To evaluate the pharmacokinetics of this regimen.

        -  To explore the association of TTP, OS, and circulating tumor tumor cell count.

      OUTLINE: Patients receive carboplatin IV over 30-60 minutes on day 1, oral prednisone twice
      daily on days on days 1-21, and oral everolimus once daily on days 2-21 of course 1 and on
      days 1-21 of subsequent courses. Courses repeat every 21 days in the absence of disease
      progression or unacceptable toxicity.

      Blood and tumor tissue samples are collected periodically for pharmacodynamic,
      pharmacokinetic, and biomarker analysis.

      After completion of study treatment, patients are followed up every 3 months.
    

Intervention name(s): carboplatin; RAD 001; prednisone; laboratory biomarker analysis; pharmacological study
Intervention type(s): Drug; Drug; Drug; Other; Other
Intervention description(s): AUC = 5 by Calvert's formula, day 1 of each 21 day cycle; 5 mg orally starting on Day 2 then continuous; 5 mg orally twice a day starting on Day 1 then continuous; Samples will be collected from archival tissue.; Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2
Other intervention name(s): Paraplatin®; Afinitor®; Zortress; Everolimus; Deltasone; Liquid Pred; Meticorten; Orasone; Prednicen-M; Prednicot; Sterapred; Sterapred DS
Intervention MeSH terms: Prednisone; Carboplatin; Everolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hormone-resistant prostate cancer; recurrent prostate cancer; stage IV prostate cancer; adenocarcinoma of the prostate