E7389 in Treating Patients With Advanced Solid Tumors - Full Text View

Sponsor:	California Cancer Consortium
Collaborator:	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

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase I Trial Of E7389 (Halichondrin B Analog) (NSC# 707389) In Patients With Advanced Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: E7389 Eribulin mesylate

U.S. FDA Resources

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

National Cancer Institute (NCI)

More Information

Additional Information:

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

No publications provided

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 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on November 09, 2009