Eribulin Mesylate and Cisplatin in Treating Patients With Advanced Solid Tumors
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Other: laboratory biomarker analysisOther: pharmacological study
- Registration Number
- NCT00415324
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- Histologically confirmed malignant solid tumor
- Advanced disease, meeting both of the following criteria: Metastatic or unresectable disease and standard curative or palliative measures do not exist or are no longer effective.
- No known active brain metastases
- Life expectancy > 3 months
- ECOG performance status 0-2
- Bilirubin normal
- No uncontrolled intercurrent illness including, but not limited to, any of the following: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness or social situation that would limit study compliance.
- Negative pregnancy test
- Fertile patients must use effective contraception
- Recovered from prior therapy
- No prior chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C).
- No prior targeted therapy within the past 4 weeks
- No prior immunotherapy within the past 4 weeks
- No prior radiotherapy within the past 4 weeks.
- No more than 2 prior chemotherapy regimens for advanced solid tumors.
- No other concurrent investigational agents. Bisphosphonate therapy (e.g., pamidronate or zolendronate) is not considered investigational therapy.
- No concurrent antiretroviral therapy for HIV-positive patients.
- No other concurrent anticancer agents or therapies.
- Tumor has spread to other parts of the body or cannot be removed by surgery.
- More than 4 weeks since chemotherapy, biological therapy, or radiation therapy.
- No more than two previous chemotherapy regimens for advanced solid tumor.
- WBC >= 3,000/mm^3
- Platelet count >= 100,000/mm^3
- Creatinine clearance >= 60 mL/min
- Absolute neutrophil count >= 1,500/mm³
- AST and ALT =< 2.5 times upper limit of normal
- No prior cumulative cisplatin dose > 300 mg/m^2
- No preexisting neuropathy <= grade 2
- Not pregnant or nursing
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 laboratory biomarker analysis Patients receive eribulin mesylate IV over 5 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1. Arm 1 pharmacological 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. Arm 1 eribulin mesylate Patients receive eribulin mesylate IV over 5 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1. Arm 1 cisplatin Patients receive eribulin mesylate IV over 5 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1.
- Primary Outcome Measures
Name Time Method Maximum tolerated dose determined by dose-limiting toxicity graded according to the NCI CTCAE version 4.0 28 days
- Secondary Outcome Measures
Name Time Method Survival From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 8 weeks Summarized with Kaplan-Meier plots to describe the outcome of patients treated on this protocol.
Time to failure Up to 8 weeks Summarized with Kaplan-Meier plots to describe the outcome of patients treated on this protocol.
Trial Locations
- Locations (4)
City of Hope Medical Center
🇺🇸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
City of Hope
🇺🇸Duarte, California, United States