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Thalidomide and Doxil® in Patients With Androgen Independent Prostate Cancer (AIPC)

NCT00307294 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-11-24

Study results available
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Summary

The primary objective of this study is to evaluate PSA response rates of the combination of Doxil and Thalidomide in patients with AIPC who have failed chemotherapy. Secondary objectives include: 1) To evaluate the clinical response rate of this combination on measurable disease 2) To evaluate overall survival for this combination.

Conditions

Interventions

DRUG

Thalidomide

100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg

DRUG

Doxil

On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days

Sponsors & Collaborators

  • Ortho Biotech, Inc.

    collaborator INDUSTRY

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Gurkamal S Chatta, MD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2012-01-31
Completion
2012-01-31

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 NCT00307294 on ClinicalTrials.gov