E7389 in Treating Patients With Advanced Solid Tumors - Tabular View

Tracking Information
First Received Date ^ICMJE	October 3, 2002
Last Updated Date	December 6, 2008
Start Date ^ICMJE	September 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00047034 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	E7389 in Treating Patients With Advanced Solid Tumors
Official Title ^ICMJE	Phase I Trial Of E7389 (Halichondrin B Analog) (NSC# 707389) In Patients With Advanced Solid Tumors
Brief Summary	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.
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.
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment
Condition ^ICMJE	Unspecified Adult Solid Tumor, Protocol Specific
Intervention ^ICMJE	Drug: eribulin mesylate
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00047034
Responsible Party
Study ID Numbers ^ICMJE	CDR0000257235, CCC-PHI-39, CHNMC-PHI-39, NCI-5730
Study Sponsor ^ICMJE	California Cancer Consortium
Collaborators ^ICMJE	National Cancer Institute (NCI)
Investigators ^ICMJE
Information Provided By	National Cancer Institute (NCI)
Verification Date	March 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP