CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
carboplatin +4 moredrug
Likely dose
RAD 001 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01051570
NCT01051570Phase 2Completed
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Phase II Trial of Carboplatin and Everolimus (RAD001) in Metastatic Castrate Resistant Prostate Cancer (CRPC) Pretreated With Docetaxel Chemotherapy.

Barbara Ann Karmanos Cancer Institute·interventional·Posted Jan 18, 2010·Updated Dec 1, 2020

In Brief

A Phase 2 clinical trial evaluating carboplatin, RAD 001, and 3 other interventions for Prostate Cancer. Completed, enrolled 26 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 18, 2010
Enrollment StartFeb 1, 2010
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 16.5 years ago

Interventions

carboplatindrug

AUC = 5 by Calvert's formula, day 1 of each 21 day cycle

RAD 001drug

5 mg orally starting on Day 2 then continuous

prednisonedrug

5 mg orally twice a day starting on Day 1 then continuous

laboratory biomarker analysisother

Samples will be collected from archival tissue.

pharmacological studyother

Samples will be collected Cycle 1, day 1, 2 \& 8 and Cycle 2, Day 1 \& 2