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A Phase II Study Of Single Agent Depsipeptide (FK228) In Breast Cancer

Phase 2
18 Years
Not Enrolling
Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

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Trial Information

A Phase II Study Of Single Agent Depsipeptide (FK228) In Breast Cancer


I. Determine the efficacy and safety of FR901228 (depsipeptide) in patients with metastatic
breast cancer.


I. Determine the clinical activity of this drug, in terms of progression-free survival, in
these patients.

OUTLINE: This is a multicenter study.

Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 2.4-12.3

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy (complete and partial response) according to RECIST

Outcome Time Frame:

Up to 14 months

Safety Issue:


Principal Investigator

Massimo Cristofanilli

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

February 2005

Completion Date:

Related Keywords:

  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer
  • Breast Neoplasms
  • Breast Neoplasms, Male



M D Anderson Cancer Center Houston, Texas  77030