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E7070 in Treating Patients With Solid Tumors

This study is ongoing, but not recruiting participants.

Sponsored by: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003976
  Purpose

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.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: indisulam
Phase I

MedlinePlus related topics:   Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase I Study to Determine the Safety of E7070 in Patients With a Solid Tumor on a Single IV Infusion Repeated Every 3 Weeks

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   30
Study Start Date:   March 1998

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.

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003976

Locations
Austria
Innsbruck Universitaetsklinik    
      Innsbruck, Austria, A-6020
Kaiser Franz Josef Hospital    
      Vienna, Austria, A-1100
Belgium
Institut Jules Bordet    
      Brussels, Belgium, 1000
Universitair Ziekenhuis Antwerpen    
      Edegem, Belgium, B-2650
U.Z. Gasthuisberg    
      Leuven, Belgium, B-3000
Ludwig Institute for Cancer Research-Brussels Branch    
      Brussels, Belgium, B-1200
Denmark
Herlev Hospital - University Hospital of Copenhagen    
      Herlev, Denmark, DK-2730
France
Centre Jean Perrin    
      Clermont-Ferrand, France, 63011
Centre Leon Berard    
      Lyon, France, 69373
CRLCC Nantes - Atlantique    
      Nantes-Saint Herblain, France, 44805
Institut Claudius Regaud    
      Toulouse, France, 31052
Institut Gustave Roussy    
      Villejuif, France, F-94805
Germany
Klinikum Nurnberg    
      Nuremberg (Nurnberg), Germany, D-90419
Universitaetsklinik und Strahlenklinik - Essen    
      Essen, Germany, D-45122
Netherlands
Academisch Ziekenhuis der Vrije Universiteit    
      Amsterdam, Netherlands, 1117 MB
Academisch Ziekenhuis Groningen    
      Groningen, Netherlands, 9713 EZ
Antoni van Leeuwenhoekhuis    
      Amsterdam, Netherlands, 1066 CX
Rotterdam Cancer Institute    
      Rotterdam, Netherlands, 3075 EA
University Medical Center Nijmegen    
      Nijmegen, Netherlands, NL-6252 HB
Norway
Norwegian Radium Hospital    
      Oslo, Norway, N-0310
Switzerland
Inselspital, Bern    
      Bern, Switzerland, CH-3010
Kantonsspital - Saint Gallen    
      Saint Gallen, Switzerland, CH-9007
University Hospital    
      Basel, Switzerland, CH-4031
United Kingdom, England
Newcastle General Hospital    
      Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
United Kingdom, Scotland
Western General Hospital    
      Edinburgh, Scotland, United Kingdom, EH4 9NQ
Ninewells Hospital and Medical School    
      Dundee, Scotland, United Kingdom, DD1 9SY
C.R.C. Beatson Laboratories    
      Glasgow, Scotland, United Kingdom, G61 1BD

Sponsors and Collaborators
European Organization for Research and Treatment of Cancer

Investigators
Study Chair:     Jean-Pierre Armand, MD     Institut Gustave Roussy    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067179, EORTC-16973, EISAI-E7070-E044-101
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003976
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific  

ClinicalTrials.gov processed this record on November 30, 2008




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