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E7389 and Cisplatin in Treating Patients With Advanced Solid Tumors
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: California Cancer Consortium
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00415324
  Purpose

RATIONALE: Drugs used in chemotherapy, such as E7389 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.

PURPOSE: This phase I trial is studying the side effects and best dose of E7389 and cisplatin in treating patients with advanced solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: cisplatin
Drug: eribulin mesylate
Procedure: pharmacological study
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Cisplatin E7389 Eribulin mesylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Study of Halichondrin B Analog (E7389) in Combination With Cisplatin in Advanced Solid Tumors

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

Primary Outcome Measures:
  • Maximum tolerated dose [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Dose-limiting toxicity [ Designated as safety issue: Yes ]
  • Survival [ Designated as safety issue: No ]
  • Time to failure [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2006
Estimated Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of E7389 and cisplatin in patients with advanced solid tumors.
  • Determine the safety and toxicity of this regimen in these patients.
  • Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive E7389 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.

Cohorts of 3-6 patients receive escalating doses of E7389 and cisplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.

Patients undergo blood collection periodically in course 1 for pharmacokinetic studies.

After completion of study treatment, patients are followed for up to 8 weeks.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant solid tumor
  • Advanced disease, meeting both of the following criteria:

    • Metastatic or unresectable disease
    • Standard curative or palliative measures do not exist or are no longer effective
  • No known active brain metastases

PATIENT CHARACTERISTICS:

  • Life expectancy > 3 months
  • ECOG performance status 0-2
  • Bilirubin normal
  • WBC ≥ 3,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine clearance ≥ 60 mL/min
  • Absolute neutrophil count ≥ 1,500/mm³
  • AST and ALT ≤ 2.5 times upper limit of 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
  • No preexisting neuropathy ≥ grade 2
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • 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 prior cumulative cisplatin dose > 300 mg/m²
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00415324

Locations
United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen     800-826-4673     becomingapatient@coh.org    
City of Hope Medical Group Recruiting
Pasadena, California, United States, 91105
Contact: Mark V. McNamara, MD     626-396-2900     mmcnamara@ccsmg.com    
Contra Costa Regional Medical Center Recruiting
Martinez, California, United States, 94553
Contact: Sharon Hiner, MD     925-370-5114     shiner@hsd.co.contra-costa.ca.us    
University of California Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Clinical Trials Office - University of California Davis Cancer     916-734-3089        
USC/Norris Comprehensive Cancer Center and Hospital Recruiting
Los Angeles, California, United States, 90089-9181
Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente     323-865-0451        
Veterans Affairs Outpatient Clinic - Martinez Recruiting
Martinez, California, United States, 94553
Contact: Nelson J. Lim, MD     925-372-2062     nelson.lim@med.va.gov    
United States, Pennsylvania
UPMC Cancer Centers Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Clinical Trials Office - UPMC Cancer Centers     412-647-8073        
Sponsors and Collaborators
California Cancer Consortium
Investigators
Study Chair: Marianna Koczywas, MD Beckman Research Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000518290, CCC-PHI-55
Study First Received: December 20, 2006
Last Updated: December 9, 2008
ClinicalTrials.gov Identifier: NCT00415324  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:
Cisplatin

Additional relevant MeSH terms:
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009