E7070 in Treating Patients With Solid Tumors

Phase I Study to Determine the Safety of E7070 in Patients With a Solid Tumor on a Single IV Infusion Repeated Every 3 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: Unspecified Adult Solid Tumor, Protocol Specific
• Intervention / Treatment: Drug: indisulam

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, A-6020
    • Innsbruck Universitaetsklinik
  • Vienna, Austria, A-1100
    • Kaiser Franz Josef Hospital
• Belgium
  • Brussels, Belgium, 1000
    • Institut Jules Bordet
  • Brussels, Belgium, B-1200
    • Ludwig Institute for Cancer Research-Brussels Branch
  • Edegem, Belgium, B-2650
    • Universitair Ziekenhuis Antwerpen
  • Leuven, Belgium, B-3000
    • U.Z. Gasthuisberg
• Denmark
  • Herlev, Denmark, DK-2730
    • Herlev Hospital - University Hospital of Copenhagen
• France
  • Clermont-Ferrand, France, 63011
    • Centre Jean Perrin
  • Lyon, France, 69373
    • Centre Leon Berard
  • 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
    • Universitaetsklinik und Strahlenklinik - Essen
  • Nuremberg (Nurnberg), Germany, D-90419
    • Klinikum Nürnberg
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Antoni van Leeuwenhoekhuis
  • Amsterdam, Netherlands, 1117 MB
    • Academisch Ziekenhuis der Vrije Universiteit
  • Groningen, Netherlands, 9713 EZ
    • Academisch Ziekenhuis Groningen
  • Nijmegen, Netherlands, NL-6252 HB
    • University Medical Center Nijmegen
  • Rotterdam, Netherlands, 3075 EA
    • Rotterdam Cancer Institute
• Norway
  • Oslo, Norway, N-0310
    • Norwegian Radium Hospital
• Switzerland
  • Basel, Switzerland, CH-4031
    • University Hospital
  • Bern, Switzerland, CH-3010
    • Inselspital, Bern
  • Saint Gallen, Switzerland, CH-9007
    • Kantonsspital - Saint Gallen
• United Kingdom
  • England
    • Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
      • Newcastle General Hospital
  • Scotland
    • Dundee, Scotland, United Kingdom, DD1 9SY
      • Ninewells Hospital and Medical School
    • Edinburgh, Scotland, United Kingdom, EH4 9NQ
      • Western General Hospital
    • Glasgow, Scotland, United Kingdom, G61 1BD
      • C.R.C. Beatson Laboratories

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed solid tumor not amenable to standard therapy No brain tumor involvement or leptomeningeal disease

PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin less than 1.5 mg/dL Transaminases and alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN for liver metastases) Renal: Creatinine no greater than 1.4 mg/dL OR Creatinine clearance at least 60 mL/min Other: No active bacterial infections (e.g., abscess or fistula) No other nonmalignant disease that precludes protocol therapy No history of alcoholism, drug addiction, or psychotic disorders that would prevent compliance No glaucoma Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) 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 for localized palliation Surgery: Not specified Other: No other concurrent investigational drugs or antitumor drugs No sulphonylureas or anti-arrhythmic agents

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Investigators: Study Chair: Jean-Pierre Armand, MD, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

Study Major Dates

• Study Start: March 1, 1998

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: May 20, 2004
• First Posted (Estimate): May 21, 2004

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: unspecified adult solid tumor, protocol specific
• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Carbonic Anhydrase Inhibitors; N-(3-chloro-7-indolyl)-1,4-benzenedisulphonamide
• Other Study ID Numbers: EORTC-16973; EISAI-E7070-E044-101