E7070 in Treating Patients With Solid Tumors

Phase 1

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00003981
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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.

Study Timeline

• Study Start: 1998-04
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-10
• Last Update Posted: 2012-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (26)

Kantonsspital - St. Gallen; 🇨🇭 St. Gallen, Switzerland

Innsbruck Universitaetsklinik; 🇦🇹 Innsbruck, Austria

Ludwig Institute for Cancer Research; 🇧🇪 Brussels, Belgium

Kaiser Franz Josef Hospital; 🇦🇹 Vienna, Austria

Herlev Hospital - University Hospital of Copenhagen; 🇩🇰 Copenhagen, Denmark

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Centre Leon Berard; 🇫🇷 Lyon, France

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

CRLCC Nantes - Atlantique; 🇫🇷 Nantes-Saint Herblain, France

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

Institut Claudius Regaud; 🇫🇷 Toulouse, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Norwegian Radium Hospital; 🇳🇴 Oslo, Norway

Erasmus University Medical Center; 🇳🇱 Rotterdam, Netherlands

Vrije Universiteit Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

Universitaetsklinikum Essen; 🇩🇪 Essen, Germany

Antoni van Leeuwenhoekhuis; 🇳🇱 Amsterdam, Netherlands

University Medical Center Nijmegen; 🇳🇱 Nijmegen, Netherlands

Inselspital, Bern; 🇨🇭 Bern, Switzerland

Academisch Ziekenhuis Groningen; 🇳🇱 Groningen, Netherlands

Royal Marsden Hospital; 🇬🇧 Sutton, England, United Kingdom

University Hospital; 🇨🇭 Basel, Switzerland

Ninewells Hospital and Medical School; 🇬🇧 Dundee, Scotland, United Kingdom

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Western General Hospital; 🇬🇧 Edinburgh, Scotland, United Kingdom

Newcastle General Hospital; 🇬🇧 Newcastle Upon Tyne, England, United Kingdom