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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 on a Single IV Infusion Repeated Every 3 Weeks
Study ID: NCT00003976
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: I. Determine the maximum tolerated dose of E7070 in patients with solid tumors. II. Assess the qualitative and quantitative toxicity in terms of predictability, duration, intensity, onset, reversibility, and dose relationship of this treatment regimen in this patient population. III. Determine a safe dose for phase II evaluation. IV. Assess the pharmacokinetics of this treatment regimen in these patients. V. Determine any possible antitumor activity of this regimen in these patients. OUTLINE: This is a dose escalation study. Patients receive E7070 IV over 1 hour once every 3 weeks. Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of E7070 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose limiting toxicity. PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 12 months.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Innsbruck Universitaetsklinik, Innsbruck, , Austria
Kaiser Franz Josef Hospital, Vienna, , Austria
Institut Jules Bordet, Brussels, , Belgium
Ludwig Institute for Cancer Research-Brussels Branch, Brussels, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
U.Z. Gasthuisberg, Leuven, , Belgium
Herlev Hospital - University Hospital of Copenhagen, Herlev, , 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
Universitaetsklinik und Strahlenklinik - Essen, Essen, , Germany
Klinikum Nurnberg, Nuremberg (Nurnberg), , Germany
Antoni van Leeuwenhoekhuis, Amsterdam, , Netherlands
Academisch Ziekenhuis der Vrije Universiteit, Amsterdam, , Netherlands
Academisch Ziekenhuis Groningen, Groningen, , Netherlands
University Medical Center Nijmegen, Nijmegen, , Netherlands
Rotterdam Cancer Institute, Rotterdam, , Netherlands
Norwegian Radium Hospital, Oslo, , Norway
University Hospital, Basel, , Switzerland
Inselspital, Bern, Bern, , Switzerland
Kantonsspital - Saint Gallen, Saint Gallen, , Switzerland
Newcastle General Hospital, Newcastle Upon Tyne, England, United Kingdom
Ninewells Hospital and Medical School, Dundee, Scotland, United Kingdom
Western General Hospital, Edinburgh, Scotland, United Kingdom
C.R.C. Beatson Laboratories, Glasgow, Scotland, United Kingdom
Name: Jean-Pierre Armand, MD
Affiliation: Gustave Roussy, Cancer Campus, Grand Paris
Role: STUDY_CHAIR