Status:
COMPLETED
Phase I-II Study of Vorinostat, Paclitaxel, and Bevacizumab in Metastatic Breast Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Male Breast Cancer
Stage IIIB 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 paclitaxel and bevacizumab and to see how well they work in treating patients with metastatic br...
Detailed Description
PRiMARY OBJECTIVES: I. To determine the recommended phase II dose of oral suberoylanilide hydroxamic acid (vorinostat) in combination with weekly paclitaxel and bevacizumab in patients with chest wal...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- histologically or cytologically confirmed adenocarcinoma of the breast; effective with version 2.2 (1/26/09), only patients with disease that is accessible to biopsy and consent to serial biopsy are eligible
- stage IV disease, locally recurrent inoperable chest wall disease; at least one bidimensional and/or unidimensional, measurable indicator lesion must be present (patients with only non-measurable disease are eligible for the phase I trial only); all sites of disease should be noted and followed
- ECOG performance status =\< 1 (Karnofsky \>= 70%)
- Absolute neutrophil count \>= 1,500/ul
- Platelets \>= 100,000/ul
- Total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) =\< 2.5 x institutional upper limit of normal
- PTT and either INR or PT \< 1.5 x normal
- Creatinine within normal institutional limits OR creatinine clearance \>= mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
- Urine protein should be screened by urine analysis for Urine Protein Creatinine (UPC) ratio; for UPC ratio \> 0.5, 24-hour urine protein should be obtained and the level should be \< 1000 mg for patient enrollment;
- LVEF must be at or above the lower institutional limit of the normal range (on MUGA or Echo obtained within 12 weeks of registration, or within 4 weeks of prior Herceptin)
- Not pregnant/lactating
- Exclusion criteria:
- chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
- may not be receiving any other investigational agents.
- history of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat or other agents used in the study (e.g., paclitaxel, bevacizumab, quinolones)
- uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00368875
Start Date
July 1 2006
End Date
December 1 2011
Last Update
November 5 2015
Active Locations (1)
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1
Montefiore Medical Center
The Bronx, New York, United States, 10467-2490