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Study of Docetaxel +153 Sm-EDTMP in Patients With Hormone-Refractory Prostate Cancer

NCT00559429 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2008-12-17

No results posted yet for this study

Summary

The primary objective of the study is to determine a recommended phase II dose (RP2D).

The secondary objective of the study are:

1. To evaluate preliminary incidence and duration of clinical benefits as determined by improvements of pain, PSA decline and bone scan changes.
2. To evaluate the toxicity profile of the escalating doses of Docetaxel in combination with Samarium 153 in patients with advanced, hormone refractory prostate cancer metastatic to the bone.

Conditions

Interventions

DRUG

Docetaxel

Docetaxel 50mg/m2 IV on day 1 and day 22

DRUG

Docetaxel

Docetaxel 75mg/m2 IV on day 1 and day 22

DRUG

Docetaxel

Docetaxel 75mg/m2 IV on day 1 and day 22

DRUG

Docetaxel

Docetaxel 75 mg/m2 IV on day 1, 22 and day 43

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Cytogen Corporation

    collaborator INDUSTRY

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Mario A. Eisenberger, M.D. · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00559429 on ClinicalTrials.gov