E7070 in Treating Patients With Solid Tumors

Phase 1

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00003976
• 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: 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.

Study Timeline

• Study Start: 1998-03
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-05-20
• Study First Posted: 2004-05-21
• 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 (27)

Klinikum Nurnberg; 🇩🇪 Nuremberg (Nurnberg), Germany

Institut Claudius Regaud; 🇫🇷 Toulouse, France

Ludwig Institute for Cancer Research-Brussels Branch; 🇧🇪 Brussels, Belgium

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

Innsbruck Universitaetsklinik; 🇦🇹 Innsbruck, Austria

Academisch Ziekenhuis der Vrije Universiteit; 🇳🇱 Amsterdam, Netherlands

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

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

Centre Leon Berard; 🇫🇷 Lyon, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

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

Antoni van Leeuwenhoekhuis; 🇳🇱 Amsterdam, Netherlands

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Universitaetsklinik und Strahlenklinik - Essen; 🇩🇪 Essen, Germany

Academisch Ziekenhuis Groningen; 🇳🇱 Groningen, Netherlands

Rotterdam Cancer Institute; 🇳🇱 Rotterdam, Netherlands

Inselspital, Bern; 🇨🇭 Bern, Switzerland

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

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

University Medical Center Nijmegen; 🇳🇱 Nijmegen, Netherlands

University Hospital; 🇨🇭 Basel, Switzerland

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

Kaiser Franz Josef Hospital; 🇦🇹 Vienna, Austria

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

C.R.C. Beatson Laboratories; 🇬🇧 Glasgow, Scotland, United Kingdom

Norwegian Radium Hospital; 🇳🇴 Oslo, Norway

Kantonsspital - Saint Gallen; 🇨🇭 Saint Gallen, Switzerland