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Phase I Study of Weekly Intravenous PS-341 (Bortezomib) Plus Mitoxantrone

NCT00059631 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2018-11-15

No results posted yet for this study

Summary

Primary Objective:

-Establish the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of weekly mitoxantrone in combination with weekly PS-341 in patients with advanced AI-PCa.

Secondary objectives:

* Evaluate the effect of bortezomib and mitoxantrone in combination on PSA levels among patients with baseline PSA levels \>/=5 ng/mL who are treated near the maximum tolerated dose.
* Monitor the effect of escalating doses of bortezomib combined with mitoxantrone on selected parameters of clinical benefit (i.e. performance status, tumor-related symptoms, measurable disease response).

Conditions

Interventions

DRUG

Mitoxantrone (Novantrone)

Starting dose of 3 mg/m\^2, four weekly intravenous injections (on Days 1, 8, 15 and 22) over eight 5 week cycles.

DRUG

Bortezomib (PS-341)

Starting Dose of 1.4 mg/m\^2, four weekly intravenous injections (on Days 1, 8, 15, and 22) over eight 5 week cycles.

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Arlene Siefker-Radtke, MD · UT M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-20
Primary Completion
2015-06-17
Completion
2015-06-17

Countries

  • United States

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 NCT00059631 on ClinicalTrials.gov