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Eribulin Mesylate and Cisplatin in Treating Patients With Advanced Solid Tumors

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00415324
Collaborator
(none)
36
Enrollment
4
Locations
1
Arm
9
Patients Per Site

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: eribulin mesylate
  • Drug: cisplatin
  • Other: laboratory biomarker analysis
  • Other: pharmacological study
 Phase 1

Detailed Description

Primary Objectives:

  1. To determine the maximum tolerated dose of E7389 and cisplatin in patients with advanced solid tumors.

  2. 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 Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Study of Halichondrin B Analog (E7389) in Combination With Cisplatin in Advanced Solid Tumors
Study Start Date :
Dec 1, 2006
Actual Primary Completion Date :
May 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: eribulin mesylate
Given IV
Other Names:
  • B1939
  • E7389
  • ER-086526
  • halichrondrin B analog

    • Drug: cisplatin
    Given IV
    Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP

    • Other: laboratory biomarker analysis
    correlative study

    Other: pharmacological study
    correlative study
    Other Names:
  • pharmacological studies

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum tolerated dose determined by dose-limiting toxicity graded according to the NCI CTCAE version 4.0 [28 days]

    Secondary Outcome Measures

    1. 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.

    2. Time to failure [Up to 8 weeks]

      Summarized with Kaplan-Meier plots to describe the outcome of patients treated on this protocol.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Medical Center Duarte California United States 91010
    2 City of Hope Duarte California United States 91010
    3 University of Southern California/Norris Cancer Center Los Angeles California United States 90033
    4 University of California at Davis Cancer Center Sacramento California United States 95817

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Marianna Koczywas, City of Hope Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00415324
    Other Study ID Numbers:
    • NCI-2009-00168
    • NCI-2009-00168
    • PHI-55
    • CDR0000518290
    • PHI-55
    • 7427
    • U01CA062505
    • P30CA033572
    First Posted:
    Dec 22, 2006
    Last Update Posted:
    May 20, 2014
    Last Verified:
    Apr 1, 2014
    Additional relevant MeSH terms:
    Neoplasms
    Cisplatin

    Study Results

    No Results Posted as of May 20, 2014