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A Phase 1 Study of Halichondrin B Analog (E7389) in Combination With Cisplatin in Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase 1 Study of Halichondrin B Analog (E7389) in Combination With Cisplatin in Advanced Solid Tumors


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose determined by dose-limiting toxicity graded according to the NCI CTCAE version 4.0

Outcome Time Frame:

28 days

Safety Issue:

Yes

Principal Investigator

Marianna Koczywas

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00168

NCT ID:

NCT00415324

Start Date:

December 2006

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Neoplasms

Name

Location

City of Hope Medical CenterDuarte, California  91010
City of HopeDuarte, California  91010
UC Davis Comprehensive Cancer CenterSacramento, California  95817
University of Southern CaliforniaLos Angeles, California  90033