E7070 in Treating Patients With Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00003981|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 11, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: indisulam||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|