NCT00415324

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	eribulin mesylate	Given IV
DRUG	cisplatin	Given IV
OTHER	laboratory biomarker analysis	correlative study
OTHER	pharmacological study	correlative study

Timeline

• Start date: 2006-12-01
• Primary completion: 2014-05-01
• First posted: 2006-12-22
• Last updated: 2014-05-20

Locations

4 sites across 1 country: United States