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Doxil, Gemcitabine, and Velcade (PS341) in Advanced Cancer Patients

NCT00500422 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2013-02-13

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest safe dose of the drug Velcade (bortezomib) that can be given together with gemcitabine and pegylated liposomal doxorubicin (Doxil) in the treatment of advanced cancer. The effect of this combination treatment on tumor growth will also be studied.

Conditions

Interventions

DRUG

Doxil

Starting dose of 20 mg/m\^2 IV over 2 hours on Day 1, 21 day cycle

DRUG

Gemcitabine

500 mg/m\^2 IV over 30 minutes on Days 1 and 8, 21 day cycle

DRUG

Velcade

Starting dose of 0.7 mg/m\^2 IV on Days 1 and 8 of first 21 day cycle; increased dose of 1.0 to 1.3 on Days 1, 4, 8, and 11 of subsequent 21 day cycles

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Gerald Falchook, MD,MS · UT MD Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT00500422 on ClinicalTrials.gov