E7070 in Treating Patients With Solid Tumors
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.
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: indisulam||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|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 Start Date:||April 1998|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003981
|Innsbruck, Austria, A-6020|
|Kaiser Franz Josef Hospital|
|Vienna, Austria, A-1100|
|Institut Jules Bordet|
|Brussels, Belgium, B-1000|
|Ludwig Institute for Cancer Research|
|Brussels, Belgium, B-1200|
|Universitair Ziekenhuis Antwerpen|
|Edegem, Belgium, B-2650|
|Leuven, Belgium, B-3000|
|Herlev Hospital - University Hospital of Copenhagen|
|Copenhagen, Denmark, DK-2730|
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63011|
|Centre Leon Berard|
|Lyon, France, 69373|
|CRLCC Nantes - Atlantique|
|Nantes-Saint Herblain, France, 44805|
|Institut Claudius Regaud|
|Toulouse, France, 31052|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Essen, Germany, D-45122|
|Vrije Universiteit Medisch Centrum|
|Amsterdam, Netherlands, 1001HV|
|Antoni van Leeuwenhoekhuis|
|Amsterdam, Netherlands, 1066 CX|
|Academisch Ziekenhuis Groningen|
|Groningen, Netherlands, 9700 RB|
|University Medical Center Nijmegen|
|Nijmegen, Netherlands, NL-6500 HB|
|Erasmus University Medical Center|
|Rotterdam, Netherlands, 3008 EA|
|Norwegian Radium Hospital|
|Oslo, Norway, N-0310|
|Basel, Switzerland, CH-4031|
|Bern, Switzerland, CH-3010|
|Kantonsspital - St. Gallen|
|St. Gallen, Switzerland, CH-9007|
|Newcastle General Hospital|
|Newcastle Upon Tyne, England, United Kingdom, NE4 6BE|
|Royal Marsden Hospital|
|Sutton, England, United Kingdom, SM2 5PT|
|Ninewells Hospital and Medical School|
|Dundee, Scotland, United Kingdom, DD1 9SY|
|Western General Hospital|
|Edinburgh, Scotland, United Kingdom, EH4 2XU|
|Study Chair:||Axel R. Hanauske, MD, PhD, MBA||University Hospital, Gasthuisberg|