FR901228 in Treating Patients With Metastatic Breast Cancer

• ClinicalTrials.gov Identifier: NCT00098397
• Recruitment Status: Completed
• First Posted: December 8, 2004
• Last Update Posted: January 24, 2013
• Sponsor: National Cancer Institute (NCI)
• Information provided by (Responsible Party): National Cancer Institute (NCI)

Study Description

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 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

Condition or disease	Intervention/treatment	Phase
Male Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer	Drug: romidepsin; Other: laboratory biomarker analysis	Phase 2

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, 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 37 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study Of Single Agent Depsipeptide (FK228) In Breast Cancer
• Study Start Date: February 2005
• Actual Primary Completion Date: September 2005

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment (romidepsin); 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.	Drug: romidepsin; Given IV; Other Names: FK228; FR901228; Istodax; Other: laboratory biomarker analysis; Optional correlative studies

Outcome Measures

Primary Outcome Measures :

1. Efficacy (complete and partial response) according to RECIST [ Time Frame: Up to 14 months ]
2. Progression-free survival [ Time Frame: 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 Outcome Measures :

1. Toxicity as measured by the standard WHO grading system [ Time Frame: Up to 14 months after completion of study treatment ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Texas

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Massimo Cristofanilli; M.D. Anderson Cancer Center

More Information

• Responsible Party: National Cancer Institute (NCI)
• ClinicalTrials.gov Identifier: NCT00098397
• Other Study ID Numbers: NCI-2012-02641; MDA-2003-0895; N01CM17003 ( U.S. NIH Grant/Contract ); CDR0000404163 ( Registry Identifier: PDQ (Physician Data Query) )
• First Posted: December 8, 2004
• Last Update Posted: January 24, 2013
• Last Verified: January 2013

Additional relevant MeSH terms:

Breast Neoplasms; Breast Neoplasms, Male; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Romidepsin; Antibiotics, Antineoplastic; Antineoplastic Agents