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Status:

COMPLETED

Eribulin Mesylate and Cisplatin in Treating Patients With Advanced Solid Tumors

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Unspecified Adult Solid Tumor, Protocol Specific

Eligibility:

All Genders

18+ years

Phase:

PHASE1

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 cispl...

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 patien...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    December 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    36 Patients enrolled

    Trial Details

    Trial ID

    NCT00415324

    Start Date

    December 1 2006

    Last Update

    May 20 2014

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    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