Status:
COMPLETED
Vorinostat and Trastuzumab in Treating Patients With Metastatic or Locally Recurrent Breast Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Male Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 b...
Detailed Description
PRIMARY OBJECTIVES: I. 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 brea...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00258349
Start Date
August 1 2006
End Date
September 1 2010
Last Update
June 2 2014
Active Locations (25)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Mercy Capitol
Des Moines, Iowa, United States, 50307
3
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
4
Iowa Oncology Research Association CCOP
Des Moines, Iowa, United States, 50309