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Male Breast CancerPhase 2NCT00098397

FR901228 in Treating Patients With Metastatic Breast Cancer

A Phase 2 study testing romidepsin and laboratory biomarker analysis in people with Male Breast Cancer and Recurrent Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
romidepsin and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteUnited States
Study dates
Feb 2005to Sep 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 54Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

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

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

Read the detailed description

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

  1. 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.

Being tested
romidepsin, laboratory biomarker analysis
Medical subject headings
Breast Neoplasms, Male, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • romidepsinDrug

    Also called FK228, FR901228, Istodax

    Given IV

  • laboratory biomarker analysisOther

    Optional correlative studies

Study groups in NCT00098397
Study groupRoleWhat they receive
Treatment (romidepsin)ExperimentalPatients 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.
Receives: Drug: romidepsin; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy (complete and partial response) according to RECIST

    Measured: Up to 14 months

  2. Progression-free survival

    Measured: From the first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 14 months

Secondary outcomes (1)

  1. Toxicity as measured by the standard WHO grading system

    Measured: Up to 14 months after completion of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2004 (estimated)
  2. Study startFeb 2005
  3. Primary completionSep 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00098397
Sponsor's protocol ID
NCI-2012-02641
Other IDs
MDA-2003-0895, N01CM17003, CDR0000404163
Status last verified
Jan 2013
First submitted
7 Dec 2004
Last updated
24 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing romidepsin and laboratory biomarker analysis in people with Male Breast Cancer and Recurrent Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 54 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy (complete and partial response) according to RECIST (time frame: Up to 14 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00098397.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.

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