MedTrace Logo

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

NCT01254513 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2021-06-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Docetaxel every 3 weeks + Prednisone

* Docetaxel IV 60 mg/m²/d then IV 70 mg/m²/d for subsequent cycles every 3 weeks * Prednisone 10 mg/day continuously

DRUG

Docetaxel weekly+ Prednisone

* Docetaxel weekly 35 mg/m²/day at day 1 and day 8 of each cycle (J1 = J21) * Prednisone 10 mg/day continuously

Sponsors & Collaborators

  • UNICANCER

    lead OTHER

Principal Investigators

  • Loic Mourey · Institut Claudius Regaud

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01254513 on ClinicalTrials.gov