Spots Global Cancer Trial Database for E7070 in Treating Patients With Solid Tumors
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Trial Identification
Brief Title: E7070 in Treating Patients With Solid Tumors
Official Title: Phase I Study to Determine the Safety of E7070 in Patients With a Solid Tumor as a Single IV Infusion Weekly X 4, Repeated Every 6 Weeks
Study ID: NCT00003981
Interventions
Study Description
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 E7070 in treating patients who have solid tumors.
Detailed Description: OBJECTIVES: * Determine the maximum tolerated dose (MTD) of E7070 when administered to adult patients with solid tumors. * Determine the qualitative and quantitative toxic effects of this drug and study the predictability, duration, intensity, onset, reversibility and dose relationship of the toxic effects in this patient population. * Propose a safe dose for phase II study. * Assess the pharmacokinetics of this drug at different dose levels in this patient population. * Determine any possible antitumor activity of this drug in this patient population. OUTLINE: This is a dose escalation study. Patients receive E7070 IV over 1 hour on days 1, 8, 15, and 22. Treatment continues every 6 weeks for at least 2 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of E7070 is escalated until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed every 3 weeks. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 12 months.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Innsbruck Universitaetsklinik, Innsbruck, , Austria
Kaiser Franz Josef Hospital, Vienna, , Austria
Institut Jules Bordet, Brussels, , Belgium
Ludwig Institute for Cancer Research, Brussels, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
U.Z. Gasthuisberg, Leuven, , Belgium
Herlev Hospital - University Hospital of Copenhagen, Copenhagen, , Denmark
Centre Jean Perrin, Clermont-Ferrand, , France
Centre Leon Berard, Lyon, , France
CRLCC Nantes - Atlantique, Nantes-Saint Herblain, , France
Institut Claudius Regaud, Toulouse, , France
Institut Gustave Roussy, Villejuif, , France
Universitaetsklinikum Essen, Essen, , Germany
Vrije Universiteit Medisch Centrum, Amsterdam, , Netherlands
Antoni van Leeuwenhoekhuis, Amsterdam, , Netherlands
Academisch Ziekenhuis Groningen, Groningen, , Netherlands
University Medical Center Nijmegen, Nijmegen, , Netherlands
Erasmus University Medical Center, Rotterdam, , Netherlands
Norwegian Radium Hospital, Oslo, , Norway
University Hospital, Basel, , Switzerland
Inselspital, Bern, Bern, , Switzerland
Kantonsspital - St. Gallen, St. Gallen, , Switzerland
Newcastle General Hospital, Newcastle Upon Tyne, England, United Kingdom
Royal Marsden Hospital, Sutton, England, United Kingdom
Ninewells Hospital and Medical School, Dundee, Scotland, United Kingdom
Western General Hospital, Edinburgh, Scotland, United Kingdom
Contact Details
Name: Axel R. Hanauske, MD, PhD, MBA
Affiliation: University Hospital, Gasthuisberg
Role: STUDY_CHAIR
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