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Breast CancerPhase 1/2NCT00258349

Vorinostat and Trastuzumab in Treating Patients With Metastatic or Locally Recurrent Breast Cancer

A Phase 1/2 study testing vorinostat and trastuzumab in people with Breast Cancer and Male Breast Cancer, run by National Cancer Institute (NCI) at 25 sites 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 I/II trial is studying the side effects and best dose of vorinostat when given together with trastuzumab and to see how well they work in treating patients with metastatic breast canceror breast cancer that has recurred in the chest wall. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
vorinostat and trastuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
25 sitesUnited States
Study dates
Aug 2006to Sep 2010
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active or ongoing infection
  • No history of allergic reaction to compounds of similar chemical or biologic composition to vorinostat or other agents used in study
  • No psychiatric illness or social situation that would preclude study compliance
Show all 37Show fewer
  • No other uncontrolled illness
  • More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin; 1 week for capecitabine) and recovered
  • More than 3 weeks since prior radiotherapy and recovered
  • Recovered from prior therapy
  • At least 2 weeks since prior valproic acid
  • More than 4 weeks since prior investigational agents
  • More than 4 weeks since prior lapatinib ditosylate
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • Measurable disease, defined as >= 1 unidimensionally measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan
  • No other concurrent investigational agents
  • Concurrent bisphosphonates allowed provided therapy was initiated prior to study treatment
  • No other concurrent anticancer therapy
  • Recurrent or progressive disease while receiving prior trastuzumab (Herceptin) (with or without chemotherapy) OR relapsed within 3 months of last dose of prior adjuvant trastuzumab for metastatic disease
  • Histologically confirmed breast cancer
  • Must overexpress HER-2 gene
  • Metastatic or chest wall recurrent disease
  • Site of measurable disease must not have been irradiated (except chest wall recurrence treated with adjuvant radiation therapy)
  • No untreated brain metastases
  • Previously treated brain metastasis responsive to radiotherapy and/or surgery allowed provided the brain is not the sole site of measurable disease
  • ECOG 0-2
  • Absolute neutrophil count >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • Hemoglobin >= 9 g/dL
  • AST and ALT =< 2 times upper limit of normal
  • Bilirubin =< 1.5 mg/dL (3 mg/dL in the presence of Gilbert's disease provided direct bilirubin is normal)
  • Creatinine =< 1.5 mg/dL
  • LVEF normal by nuclear scan or echocardiogram
  • No evidence of PR prolongation or AV block by EKG
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Who cannot join

None listed.

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

United States25 sites

  • Johns Hopkins University

    Baltimore, Maryland, 21287-8936

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Eastern Cooperative Oncology Group

    Boston, Massachusetts, 02215

  • Mercy Capitol

    Des Moines, Iowa, 50307

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa Oncology Research Association CCOP

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Meeker County Memorial Hospital

    Litchfield, Minnesota, 55355

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Virginia Piper Cancer Institute

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Saint Vincent's Hospital and Medical Center of New York

    New York, New York, 10011

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • Saint Joseph's Hospital - Healtheast

    Saint Paul, Minnesota, 55102

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Siouxland Hematology Oncology Associates

    Sioux City, Iowa, 51101

  • Mercy Medical Center-Sioux City

    Sioux City, Iowa, 51104

  • Saint Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461

  • Montefiore Medical Center

    The Bronx, New York, 10467-2490

  • Woodwinds Health Campus

    Woodbury, Minnesota, 55125

Other trials in United States

About this study

Official title: A Phase I/II Study of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Trastuzumab (Herceptin) in Patients With Advanced Metastatic and/or Local Chest Wall Recurrent Her-2 Amplified Breast Cancer

This phase I/II trial is studying the side effects and best dose of vorinostat when given together with trastuzumab and to see how well they work in treating patients with metastatic breast canceror breast cancer that has recurred in the chest wall. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Vorinostat and trastuzumab also may stop the growth of tumor cells by blocking blood flow to the tumor. Giving vorinostat together with trastuzumab may be a better way to block tumor growth.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the maximum tolerated dose of vorinostat in combination with trastuzumab (Herceptin) in patients with metastatic or local chest wall recurrent HER-2-amplified breast cancer. (Phase I) II. To determine the toxic effects of this regimen in these patients. (Phase I) III. To determine the response rate in patients treated with this regimen. (Phase II)

SECONDARY OBJECTIVE:

  1. To determine the time to progression in patients treated with this regimen. (Phase II)

OUTLINE: This is an open-label, multicenter, dose-escalation study of vorinostat.

PHASE I: Patients receive oral vorinostat twice daily on days 1-14 and trastuzumab (Herceptin®) IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of vorinostat until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity. At least 6 patients are treated at the MTD.

PHASE II: Patients receive vorinostat at the MTD and trastuzumab as in phase I.

After completion of study treatment, patients are followed periodically for 3 years.

Being tested
vorinostat, trastuzumab
Medical subject headings
Breast Neoplasms, Breast Neoplasms, Male

What participants receive

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

Study groups in NCT00258349
Study groupRoleWhat they receive
Arm IExperimentalPatients will receive vorinostat by mouth twice a day for 2 weeks. They will also receive a 90-minute infusion of trastuzumab in week 1.
Receives: Drug: vorinostat; Drug: trastuzumab

What is being measured

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

  1. Response Rate

    Tumor response is assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Response included complete response (CR) and partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.

    Measured: Tumor assessment was obtained at baseline, after 6 weeks (week 6 = last week of Cycle 2), and after every 4 cycles of therapy

Secondary outcomes (2)

  1. Time to Progression

    Tumor response is assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Disease progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s). Time to progression is defined as time from registration to disease progression.

    Measured: Tumor assessment was obtained at baseline, after 6 weeks (week 6 = last week of Cycle 2), and after every 4 cycles of therapy

  2. Overall Survival

    Overall survival is defined as time from registration to death from any cause. Patients who were alive were censored as the last date of known alive.

    Measured: Survival was assessed every 3 months for first 2 years from protocol entry, then every 6 months until 3 years from study entry

Timeline

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

  1. First posted24 Nov 2005 (estimated)
  2. Study startAug 2006
  3. Primary completionAug 2010
  4. Study completionSep 2010

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00258349
Sponsor's protocol ID
NCI-2009-00503
Other IDs
NCI-2009-00503, CDR0000449963, E1104, E1104, U10CA021115
Status last verified
Oct 2013
First submitted
22 Nov 2005
Last updated
2 Jun 2014

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing vorinostat and trastuzumab in people with Breast Cancer and Male Breast Cancer, run by National Cancer Institute (NCI) at 25 sites 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 37 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 2 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Yes. Results are posted in the registry (first posted 27 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Response Rate (time frame: Tumor assessment was obtained at baseline, after 6 weeks (week 6 = last week of Cycle 2), and after every 4 cycles of therapy). 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 NCT00258349.

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 2 Jun 2014.

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