Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI, Other	CDR0000438776 CCC-PHII-62, NCI-6918, NCI-P6918, NCT00132002

Trial Description

Summary

RATIONALE: Drugs used in chemotherapy, such as suberoylanilide hydroxamic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating patients with progressive stage IV breast cancer.

Further Study Information

OBJECTIVES:

Primary

• Determine the objective tumor response rate in patients with progressive stage IV adenocarcinoma of the breast treated with suberoylanilide hydroxamic acid as salvage therapy.

Secondary

• Determine the time to progression and overall survival of patients treated with this drug.

• Determine the toxicity profile of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral suberoylanilide hydroxamic acid twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 8 weeks.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 4-12 months.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the breast

• Stage IV disease

• Tumor blocks and/or slides from original diagnosis or metastatic disease work-up must be available

• Progressive disease after 1 or 2 prior chemotherapy regimens for metastatic disease

• Chemotherapy regimen(s) may have included trastuzumab (Herceptin®) for HER2/neu-positive disease

• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by conventional techniques OR > 10 mm by spiral CT scan

• No known brain metastases unless they are controlled after prior therapy AND patient has not been treated with steroids within the past 2 months

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Female or male

Menopausal status

• Not specified

Performance status

• ECOG 0-2

Life expectancy

• More than 6 months

Hematopoietic

• Absolute neutrophil count ≥ 1,000/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 2 mg/dL

• AST and ALT ≤ 3 times upper limit of normal

Renal

• Creatinine ≤ 1.6 mg/dL OR

• Creatinine clearance ≥ 60 mL/min

Cardiovascular

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

Other

• 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 biological composition to study drug, including any of the following:

• Sodium butyrate

• Trichostatin A

• Trapoxin

• MS-27-275

• Depsipeptide

• No psychiatric illness or social situation that would preclude study compliance

• No ongoing or active infection

• No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

• No concurrent filgrastim (G-CSF) for chemotherapy-induced neutropenia

Chemotherapy

• See Disease Characteristics

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

• See Disease Characteristics

• Prior hormonal therapy allowed

Radiotherapy

• More than 4 weeks since prior radiotherapy

Surgery

• Not specified

Other

• Recovered from all prior therapy

• Prior adjuvant therapy for metastatic disease allowed

• At least 2 weeks since prior valproic acid

• No other concurrent investigational agents

• No other concurrent anticancer therapy

• No concurrent combination antiretroviral therapy for HIV-positive patients

Trial Contact Information

Trial Lead Organizations/Sponsors

California Cancer Consortium

Thehang H. Luu

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00132002
Information obtained from ClinicalTrials.gov on October 06, 2009

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