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Eribulin Mesylate and Cisplatin in Treating Patients With Advanced Solid Tumors

A Phase 1 Study of Halichondrin B Analog (E7389) in Combination With Cisplatin in Advanced Solid Tumors

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00415324
Enrollment
36
Registered
2006-12-22
Start date
2006-12-31
Completion date
Unknown
Last updated
2014-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

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.

Interventions

DRUGeribulin mesylate

Given IV

DRUGcisplatin

Given IV

OTHERlaboratory biomarker analysis

correlative study

OTHERpharmacological study

correlative study

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Maximum tolerated dose determined by dose-limiting toxicity graded according to the NCI CTCAE version 4.028 days

Secondary

MeasureTime frameDescription
SurvivalFrom first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 8 weeksSummarized with Kaplan-Meier plots to describe the outcome of patients treated on this protocol.
Time to failureUp to 8 weeksSummarized with Kaplan-Meier plots to describe the outcome of patients treated on this protocol.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026