FR901228 in Treating Patients With Metastatic Breast Cancer

Completed · Phase 2

Conditions studied: Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

In brief

This phase II trial is studying how well FR901228 works in treating patients with metastatic breast cancer. Drugs used in chemotherapy, such as FR901228, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. FR901228 may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Key facts

Study ID: NCT00098397
Run by: National Cancer Institute (NCI)
People needed: 37
Starts: 2005-02-01
Last updated by the study team: 2013-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically or cytologically confirmed breast cancer
Metastatic disease
Measurable disease
At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
The following are not considered measurable disease:
Bone disease only
Pleural effusion
Peritoneal effusion
Must have received prior anthracycline (doxorubicin or epirubicin) and/or taxane (paclitaxel or docetaxel) as adjuvant therapy or for advanced disease
Therapy with high-dose regimens or bone marrow transplantation is considered 1 prior regimen
No known brain metastases
Hormone receptor status:
Not specified
Male or female
Performance status - ECOG 0-1
Performance status - Karnofsky 70-100%
More than 12 weeks
Absolute neutrophil count ≥ 1,500/mm\^3
WBC ≥ 3,000/mm\^3
Platelet count ≥ 100,000/mm\^3
Bilirubin normal
AST or ALT ≤ 2.5 times upper limit of normal
Creatinine normal
Creatinine clearance ≥ 60 mL/min
QTc < 500 msec

Where it is running

M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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