Eribulin Mesylate and Cisplatin in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00415324
First received: December 20, 2006
Last updated: May 19, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: eribulin mesylate
Drug: cisplatin
Other: laboratory biomarker analysis
Other: pharmacological study
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study of Halichondrin B Analog (E7389) in Combination With Cisplatin in Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose determined by dose-limiting toxicity graded according to the NCI CTCAE version 4.0 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Survival [ Time Frame: From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 8 weeks ] [ Designated as safety issue: No ]
    Summarized with Kaplan-Meier plots to describe the outcome of patients treated on this protocol.

  • Time to failure [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
    Summarized with Kaplan-Meier plots to describe the outcome of patients treated on this protocol.


Enrollment: 36
Study Start Date: December 2006
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: pharmacological studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415324

Locations
United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
City of Hope
Duarte, California, United States, 91010
University of Southern California/Norris Cancer Center
Los Angeles, California, United States, 90033
University of California at Davis Cancer Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
Investigators
Principal Investigator: Marianna Koczywas City of Hope Medical Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00415324     History of Changes
Other Study ID Numbers: NCI-2009-00168, NCI-2009-00168, PHI-55, CDR0000518290, PHI-55, 7427, U01CA062505, P30CA033572
Study First Received: December 20, 2006
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 19, 2014