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E7389 in Treating Patients With Advanced Solid Tumors
This study has been completed.
Sponsors and Collaborators: California Cancer Consortium
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00047034
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of E7389 in treating patients who have advanced solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: eribulin mesylate
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: E7389 Eribulin mesylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Trial Of E7389 (Halichondrin B Analog) (NSC# 707389) In Patients With Advanced Solid Tumors

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

Study Start Date: September 2002
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of E7389 in patients with advanced solid tumors.
  • Determine the toxic effects of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.
  • Determine the in vivo anti-mitotic activity of this drug before and after treatment in these patients.
  • Determine, preliminarily, the target validation feasibility of this drug in patients with biopsy-accessible tumor.
  • Determine the clinical response in patients treated with this drug.

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

Patients receive E7389 IV over 1-2 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of E7389 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.

Additional patients with biopsy-accessible tumors are accrued and treated as above at the MTD.

PROJECTED ACCRUAL: Approximately 31 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 solid tumor refractory to standard therapy or for which no standard therapy exists

    • Tumors must be accessible for repeated biopsy in patients in the expanded cohort (at the maximum tolerated dose)
  • Evaluable disease

    • Pleural effusions, ascites, and bone metastases are evaluable
  • No brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • At least 2 months

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 mg/dL
  • SGOT and SGPT no greater than 2.5 times upper limit of normal

Renal

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular

  • No poorly controlled cardiovascular disease
  • No severe cardiovascular disease that would preclude study

Pulmonary

  • No poorly controlled pulmonary disease
  • No severe pulmonary disease that would preclude study

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No poorly controlled CNS disease
  • No severe CNS disease that would preclude study
  • No other poorly controlled nonmalignant disease
  • No other severe nonmalignant disease that would preclude study
  • No active severe infection requiring therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and 8 weeks for UCN-01) and recovered

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Recovered from prior major surgery

Other

  • No concurrent antiretroviral medications for HIV-positive patients
  • No other concurrent investigational drugs
  • No other concurrent antineoplastic therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047034

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
City of Hope Medical Group
Pasadena, California, United States, 91105
University of California Davis Cancer Center
Sacramento, California, United States, 95817
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033
Sponsors and Collaborators
California Cancer Consortium
  More Information

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

Study ID Numbers: CDR0000257235, CCC-PHI-39, CHNMC-PHI-39, NCI-5730
Study First Received: October 3, 2002
Last Updated: December 6, 2008
ClinicalTrials.gov Identifier: NCT00047034  
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on January 15, 2009