NCT01051570

Carboplatin, Everolimus, and Prednisone in Treating Patients With Metastatic Prostate Cancer That Progressed After Docetaxel

Phase II Trial of Carboplatin and Everolimus (RAD001) in Metastatic Castrate Resistant Prostate Cancer (CRPC) Pretreated With Docetaxel Chemotherapy.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	carboplatin	AUC = 5 by Calvert's formula, day 1 of each 21 day cycle
DRUG	RAD 001	5 mg orally starting on Day 2 then continuous
DRUG	prednisone	5 mg orally twice a day starting on Day 1 then continuous
OTHER	laboratory biomarker analysis	Samples will be collected from archival tissue.
OTHER	pharmacological study	Samples will be collected Cycle 1, day 1, 2 \& 8 and Cycle 2, Day 1 \& 2

Timeline

• Start date: 2010-02-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2010-01-18
• Last updated: 2020-12-01
• Results posted: 2014-08-25

Locations

4 sites across 1 country: United States