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Sponsors and Collaborators: |
California Cancer Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00047034 |
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 |
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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 |
Study Start Date: | September 2002 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor refractory to standard therapy or for which no standard therapy exists
Evaluable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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 |
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 |
unspecified adult solid tumor, protocol specific |