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E7070 in Treating Patients With Solid Tumors

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC (Other)
Overall Status
Completed
CT.gov ID
NCT00003976
Collaborator
(none)
30
Enrollment
27
Locations
1.1
Patients Per Site

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose of E7070 in patients with solid tumors.

  1. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Primary Purpose:
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
Study Start Date :
Mar 1, 1998

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Locations

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

    Sponsors and Collaborators

    • European Organisation for Research and Treatment of Cancer - EORTC

    Investigators

    • Study Chair: Jean-Pierre Armand, MD, Gustave Roussy, Cancer Campus, Grand Paris

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    European Organisation for Research and Treatment of Cancer - EORTC
    ClinicalTrials.gov Identifier:
    NCT00003976
    Other Study ID Numbers:
    • EORTC-16973
    • EORTC-16973
    • EISAI-E7070-E044-101
    First Posted:
    May 21, 2004
    Last Update Posted:
    Jul 11, 2012
    Last Verified:
    Jul 1, 2012
    Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC
    unspecified adult solid tumor, protocol specific
    Additional relevant MeSH terms:
    Neoplasms
    N-(3-chloro-7-indolyl)-1,4-benzenedisulphonamide

    Study Results

    No Results Posted as of Jul 11, 2012