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


Phase 2
18 Years
N/A
Not Enrolling
Both
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


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, 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
months.


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:

Interventional

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:

No

Principal Investigator

Massimo Cristofanilli

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02641

NCT ID:

NCT00098397

Start Date:

February 2005

Completion Date:

Related Keywords:

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

Name

Location

M D Anderson Cancer CenterHouston, Texas  77030