E7070 in Treating Patients With Solid Tumors

NCT00003981 | Completed Phase 1

• 2 other identifiers: EORTC-16975EISAI-E7070-E044-103
• Study Type: interventional
• Target: 30
• Locations: 9 countries
• Sites: 26

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

indisulam DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (26)

Innsbruck Universitaetsklinik

Innsbruck, A-6020, Austria

Location

Kaiser Franz Josef Hospital

Vienna, A-1100, Austria

Location

Institut Jules Bordet

Brussels, B-1000, Belgium

Location

Ludwig Institute for Cancer Research

Brussels, B-1200, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Herlev Hospital - University Hospital of Copenhagen

Copenhagen, DK-2730, Denmark

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

CRLCC Nantes - Atlantique

Nantes-Saint Herblain, 44805, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Universitaetsklinikum Essen

Essen, D-45122, Germany

Location

Vrije Universiteit Medisch Centrum

Amsterdam, 1001HV, Netherlands

Location

Antoni van Leeuwenhoekhuis

Amsterdam, 1066 CX, Netherlands

Location

Academisch Ziekenhuis Groningen

Groningen, 9700 RB, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Erasmus University Medical Center

Rotterdam, 3008 EA, Netherlands

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

University Hospital

Basel, CH-4031, Switzerland

Location

Inselspital, Bern

Bern, CH-3010, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Royal Marsden Hospital

Sutton, England, SM2 5PT, United Kingdom

Location

Ninewells Hospital and Medical School

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

MeSH Terms

Interventions

N-(3-chloro-7-indolyl)-1,4-benzenedisulphonamide

Study Officials

• Axel R. Hanauske, MD, PhD, MBA

  University Hospital, Gasthuisberg

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: April 1, 1998
• Last Updated: July 11, 2012

Record last verified: 2012-07

Locations

BE (4); NL (5); FR (5); GB (4); DK (1); NO (1); AU (2); CH (3); DE (1)