Eribulin Mesylate and Cisplatin in Treating Patients With Advanced Solid Tumors

NCT ID: NCT00415324

Last Updated: 2014-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

Patients receive eribulin mesylate IV over 5 minutes on days 1, 8, and 15 and cisplatin IV over 30-60 minutes on day 1.

Group Type: EXPERIMENTAL

eribulin mesylate

Intervention Type: DRUG

Given IV

cisplatin

Intervention Type: DRUG

Given IV

laboratory biomarker analysis

Intervention Type: OTHER

correlative study

pharmacological study

Intervention Type: OTHER

correlative study

Interventions

eribulin mesylate

Given IV

Intervention Type: DRUG

cisplatin

Given IV

Intervention Type: DRUG

laboratory biomarker analysis

correlative study

Intervention Type: OTHER

pharmacological study

correlative study

Intervention Type: OTHER

Other Intervention Names

B1939; E7389; ER-086526; halichrondrin B analog; CACP; CDDP; CPDD; DDP; pharmacological studies

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marianna Koczywas

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

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

Countries

United States

Other Identifiers

NCI-2009-00168

Identifier Type: REGISTRY

Identifier Source: secondary_id

PHI-55

Identifier Type: -

Identifier Source: secondary_id

CDR0000518290

Identifier Type: -

Identifier Source: secondary_id

PHI-55

Identifier Type: OTHER

Identifier Source: secondary_id

7427

Identifier Type: OTHER

Identifier Source: secondary_id

U01CA062505

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-00168

Identifier Type: -

Identifier Source: org_study_id