Clinical Trials Directory

Trials / Terminated

TerminatedNCT00096109

Tanespimycin in Treating Women With Refractory Locally Advanced or Metastatic Breast Cancer

A Phase II Clinical Trial of 17-Allyamino-17-Demethoxygeldanamycin (17-AAG) in Chemotherapy Refractory Metastatic Breast Cancer

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
11 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial is studying how well tanespimycin works in treating women with refractory locally advanced or metastatic breast cancer. Drugs used in chemotherapy, such as tanespimycin, work in different ways to stop tumor cells from dividing so they stop growing or die

Detailed description

PRIMARY OBJECTIVES: I. To determine the response rate of 17-Allylamino-17-Demethoxygeldanamycin (17-AAG) (tanespimycin) in patients with refractory/resistant metastatic breast cancer. II. To determine the progression free survival (PFS) of patients with refractory/resistant metastatic breast cancer when treated with 17-AAG. III. To correlate patients' her2/neu status with response to 17-AAG treatment. OUTLINE: This is a multicenter study. Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed at day 30, every 10-12 weeks until disease progression, and then every 3 months thereafter.

Conditions

Interventions

TypeNameDescription
DRUGtanespimycinGiven IV
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2005-09-01
Primary completion
2012-05-01
Completion
2012-05-01
First posted
2004-11-09
Last updated
2017-01-16
Results posted
2017-01-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00096109. Inclusion in this directory is not an endorsement.