E7070 in Treating Patients With Solid Tumors

July 10, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, A-6020
        • Innsbruck Universitaetsklinik
      • Vienna, Austria, A-1100
        • Kaiser Franz Josef Hospital
  • Belgium
      • Brussels, Belgium, B-1000
        • Institut Jules Bordet
      • Brussels, Belgium, B-1200
        • Ludwig Institute for Cancer Research
      • Edegem, Belgium, B-2650
        • Universitair Ziekenhuis Antwerpen
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
  • Denmark
      • Copenhagen, Denmark, DK-2730
        • Herlev Hospital - University Hospital of Copenhagen
  • France
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Lyon, France, 69373
        • Centre Léon Bérard
      • Nantes-Saint Herblain, France, 44805
        • CRLCC Nantes - Atlantique
      • Toulouse, France, 31052
        • Institut Claudius Regaud
      • Villejuif, France, F-94805
        • Institut Gustave Roussy
  • Germany
      • Essen, Germany, D-45122
        • Universitaetsklinikum Essen
  • Netherlands
      • Amsterdam, Netherlands, 1001HV
        • Vrije Universiteit Medisch Centrum
      • Amsterdam, Netherlands, 1066 CX
        • Antoni van Leeuwenhoekhuis
      • Groningen, Netherlands, 9700 RB
        • Academisch Ziekenhuis Groningen
      • Nijmegen, Netherlands, NL-6500 HB
        • University Medical Center Nijmegen
      • Rotterdam, Netherlands, 3008 EA
        • Erasmus University Medical Center
  • Norway
      • Oslo, Norway, N-0310
        • Norwegian Radium Hospital
  • Switzerland
      • Basel, Switzerland, CH-4031
        • University Hospital
      • Bern, Switzerland, CH-3010
        • Inselspital, Bern
      • St. Gallen, Switzerland, CH-9007
        • Kantonsspital - St. Gallen
  • United Kingdom
    • England
      • Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
        • Newcastle General Hospital
      • Sutton, England, United Kingdom, SM2 5PT
        • Royal Marsden Hospital
    • Scotland
      • Dundee, Scotland, United Kingdom, DD1 9SY
        • Ninewells Hospital and Medical School
      • Edinburgh, Scotland, United Kingdom, EH4 2XU
        • Western General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed solid tumor that is not amenable to standard therapy
  • No brain involvement or leptomeningeal disease

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • WHO 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL

Hepatic:

  • Bilirubin less than 1.5 mg/dL
  • Liver function tests no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases present)

Renal:

  • Creatinine no greater than 1.4 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No active bacterial infections (e.g., abscess or fistulae)
  • No other nonmalignant disease that precludes protocol therapy
  • No history of alcoholism, drug addiction, or psychotic disorders that preclude participation
  • No glaucoma

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  • No other concurrent antitumor drugs

Endocrine therapy:

  • At least 4 weeks since prior anticancer hormonal therapy

Radiotherapy:

  • At least 4 weeks since prior radiotherapy (6 weeks for extensive radiotherapy)
  • No concurrent radiotherapy (except localized palliative radiotherapy)

Surgery:

  • Not specified

Other:

  • No concurrent sulfonylurea agent for diabetes or antiarrhythmic agents
  • No other concurrent investigational drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Axel R. Hanauske, MD, PhD, MBA, University Hospital, Gasthuisberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1998

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 11, 2012

Last Update Submitted That Met QC Criteria

July 10, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-16975
  • EISAI-E7070-E044-103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe