Status:
COMPLETED
FR901228 in Treating Patients With Metastatic Breast Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Male Breast Cancer
Recurrent Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 t...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the efficacy and safety of FR901228 (depsipeptide) in patients with metastatic breast cancer. SECONDARY OBJECTIVES: I. Determine the clinical activity of this drug,...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- No New York Heart Association class III or IV congestive heart failure
- No myocardial infarction within the past year
- No uncontrolled dysrhythmia
- No poorly controlled angina
- No other significant cardiac disease
- No history of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of allergic reaction attributed to compounds of similar chemical or biologic composition to FR901228
- No active or ongoing infection
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
- No concurrent biologic agents
- No more than 1 prior chemotherapy regimen for metastatic disease
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- No prior FR901228 (depsipeptide)
- No other concurrent chemotherapy
- Prior hormonal therapy for metastatic disease or as adjuvant therapy allowed
- More than 4 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
- More than 2 weeks since prior minor surgery and recovered
- More than 4 weeks since prior major surgery and recovered
- Concurrent bisphosphonates allowed provided therapy was initiated ≥ 3 months ago
- No concurrent agents that cause QTc prolongation
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No concurrent drugs known to have histone deacetylase activity (e.g., valproic acid)
- No other concurrent investigational agents
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00098397
Start Date
February 1 2005
Last Update
January 24 2013
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030