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E7070 in Treating Patients With Stage IV Melanoma

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC (Other)
Overall Status
Completed
CT.gov ID
NCT00014625
Collaborator
(none)
28
Enrollment
12
Locations
2.3
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 II trial to study the effectiveness of E7070 in treating patients who have stage IV melanoma.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES: I. Determine the therapeutic activity of E7070 in terms of objective response, duration of response, and progression-free survival of patients with metastatic melanoma. II. Determine the acute side effects of this drug in these patients. III. Determine the pharmacokinetic parameters of this drug in these patients.

OUTLINE: This is a multicenter study. Patients receive E7070 IV over 1 hour. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks.

PROJECTED ACCRUAL: A total of 19-24 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Primary Purpose:
Treatment
Official Title:
Open Label Phase II Study Of E7070 In Patients With Metastatic Melanoma (Stage IV)
Study Start Date :
Feb 1, 2001
Actual Primary Completion Date :
Nov 1, 2001

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    DISEASE CHARACTERISTICS: Histologically confirmed stage IV melanoma Metastatic disease At least 1 bidimensionally measurable target lesion by CT scan No brain metastases

    PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR WHO 0-2 Life expectancy: Not specified Hematopoietic: Hemoglobin greater than 10 g/dL Neutrophil count greater than 2,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastases present) Transaminases no greater than 2.5 times ULN (5 times ULN if liver metastases present) Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular: Clinically normal cardiac function No history of severe or unstable ischemic heart disease 12-lead ECG normal Other: No history of unstable systemic disease No concurrent uncontrolled diabetes mellitus No concurrent infection No history of hypersensitivity to sulfonamides No other malignancy within the past 5 years except cone-biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer No psychological, familial, sociological, or geographical condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

    PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior blood transfusions At least 2 weeks since prior growth factors At least 6 weeks since prior experimental vaccine therapy No prior immunotherapy for metastatic disease No concurrent anticancer immunotherapy Chemotherapy: No prior chemotherapy for metastatic disease No other concurrent anticancer chemotherapy Endocrine therapy: No concurrent anticancer hormonal therapy Radiotherapy: No concurrent anticancer radiotherapy except palliation for pain control or other reasons (e.g., bronchial obstruction or ulcerating skin lesions) with no curative intent Surgery: Not specified Other: At least 6 weeks since prior adjuvant or neoadjuvant therapy At least 4 weeks since prior experimental drugs At least 2 weeks since prior and no concurrent coumarin anti-coagulants, terfenadine, cisapride, cyclosporine, tacrolimus, theophylline, diazepam, sulfonylurea anti-diabetics, phenytoin, or carbamazepine No other concurrent experimental agents

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kaiser Franz Josef Hospital Vienna Austria A-1100
    2 Institut Jules Bordet Brussels Belgium 1000
    3 Centre Jean Perrin Clermont-Ferrand France 63011
    4 Centre Leon Berard Lyon France 69373
    5 Centre Eugene Marquis Rennes France 35064
    6 Medizinische Hochschule Hannover Hannover Germany D-30625
    7 Istituto Nazionale per lo Studio e la Cura dei Tumori Naples Italy 80131
    8 Norwegian Radium Hospital Oslo Norway N-0310
    9 Instituto Portugues de Oncologia de Francisco Gentil Lisbon Portugal 1093
    10 Centre Hospitalier Universitaire Vaudois Lausanne Switzerland CH-1011
    11 Royal Marsden NHS Trust London England United Kingdom SW3 6JJ
    12 Western General Hospital Edinburgh Scotland United Kingdom EH4 2XU

    Sponsors and Collaborators

    • European Organisation for Research and Treatment of Cancer - EORTC

    Investigators

    • Study Chair: John F. Smyth, MD, Edinburgh Cancer Centre at Western General Hospital
    • Study Chair: Steinar Aamdal, MD, PhD, Norwegian Radium Hospital

    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:
    NCT00014625
    Other Study ID Numbers:
    • EORTC-16005-18002
    • EORTC-16005
    • EORTC-18002
    • EISAI-E7070-E044-205
    First Posted:
    Feb 16, 2004
    Last Update Posted:
    Jul 24, 2012
    Last Verified:
    Jul 1, 2012
    Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC
    stage IV melanoma
    recurrent melanoma
    Additional relevant MeSH terms:
    Melanoma
    N-(3-chloro-7-indolyl)-1,4-benzenedisulphonamide

    Study Results

    No Results Posted as of Jul 24, 2012