Trial intelligence / Profile preview

Carboplatin-Etoposide in Hormone-Resistant Prostate Cancer with Neuroendocrine Differentiation

NCT00973882Phase 2

Key facts

Status: Completed
Start: Apr 2005
Primary completion: Jul 2009
Countries: 1
Sponsor: Centre Léon Bérard
Modality: DNA Intercalators/Alkylators

Drugs: carboplatinetoposide
Conditions: prostate cancer (PCa)

Overview

Phase 2, open-label, single-arm trial of carboplatin and etoposide in prostate cancer (PCa), sponsored by Centre Léon Bérard. Primary endpoints: Objective Response Rate, Prostate Specific Antigen Response and 1 more. Started Apr 2005; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Carboplatin-Etoposide
Carboplatin and Etoposide combination therapy

Who it enrols

Patients with metastatic hormone-resistant prostate adenocarcinoma showing neuroendocrine differentiation (elevated NSE/CgA or histological evidence), prior hormonal therapy failure, and adequate organ function.

Endpoints

Primary

Objective Response Rate3-4 weeks post-treatment
Prostate Specific Antigen Response3-4 weeks post-treatment
Neuro-endocrine Marker Response3-4 weeks post-treatment

Secondary

Duration of ResponseEvery 3 months until progression
ToxicityEvery 3 weeks during treatment
Progression-Free SurvivalEvery 3 months until progression
Overall SurvivalEvery 3 months until progression

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