drugset / Trial / NCT01254513

Feasibility of a Chemotherapy With Docetaxel-Prednisone for Castration-resistant Metastatic Prostate Cancer Elderly Patients

NCT01254513 ↗

Phase 2 Completed 66 enrolled UNICANCER
RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of this study is to evaluate the feasibility of two different chemotherapy protocols with adjusted doses for patients aged 75 and over who often have medical problems other than prostate cancer. Patient will receive Docetaxel either every 3 weeks or weekly. In both cases, chemotherapy is combined with prednisone. The protocol will be considered feasible when patient will receive 6 cycles of chemotherapy (1 cycle = 3 weeks). Additionally to this primary objective, efficacy will also be evaluated for both protocols as well as tolerance to treatment, quality of life and evolution of geriatric data.

Timeline

Start
2010-12-09
Primary completion
2014-05-10
Completion
2017-04-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 35 mg/m2 Intravenous
Subject Docetaxel Small molecule 70 mg/m2 Intravenous
Background Prednisone Other / unclassified 10 mg —

Indications