This trial is studying the side effects and best dose of eribulin mesylate and cisplatin in treating patients with advanced solid tumors.Drugs used in chemotherapy, such as eribulin mesylate and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Primary Objectives: I. To determine the maximum tolerated dose of E7389 and cisplatin in patients with advanced solid tumors. II. To determine the safety and toxicity of this regimen in these patients. III. To determine the pharmacokinetics of this regimen in these patients. Outline: This is a multicenter, dose-escalation study. Patients receive eribulin mesylate IV over 5 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for up to 8 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
City of Hope Medical Center
Duarte, California, United States
City of Hope
Duarte, California, United States
University of Southern California/Norris Cancer Center
Los Angeles, California, United States
University of California at Davis Cancer Center
Sacramento, California, United States
Maximum tolerated dose determined by dose-limiting toxicity graded according to the NCI CTCAE version 4.0
Time frame: 28 days
Survival
Summarized with Kaplan-Meier plots to describe the outcome of patients treated on this protocol.
Time frame: From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 8 weeks
Time to failure
Summarized with Kaplan-Meier plots to describe the outcome of patients treated on this protocol.
Time frame: Up to 8 weeks
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correlative study