Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
28 participants
INTERVENTIONAL
2001-02-28
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of E7070 in treating patients who have stage IV melanoma.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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indisulam
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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John F. Smyth, MD
Role: STUDY_CHAIR
Edinburgh Cancer Centre at Western General Hospital
Steinar Aamdal, MD, PhD
Role: STUDY_CHAIR
Norwegian Radium Hospital
Locations
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Kaiser Franz Josef Hospital
Vienna, , Austria
Institut Jules Bordet
Brussels, , Belgium
Centre Jean Perrin
Clermont-Ferrand, , France
Centre Leon Berard
Lyon, , France
Centre Eugene Marquis
Rennes, , France
Medizinische Hochschule Hannover
Hanover, , Germany
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, , Italy
Norwegian Radium Hospital
Oslo, , Norway
Instituto Portugues de Oncologia de Francisco Gentil
Lisbon, , Portugal
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Royal Marsden NHS Trust
London, England, United Kingdom
Western General Hospital
Edinburgh, Scotland, United Kingdom
Countries
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References
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Smyth JF, Aamdal S, Awada A, Dittrich C, Caponigro F, Schoffski P, Gore M, Lesimple T, Djurasinovic N, Baron B, Ravic M, Fumoleau P, Punt CJ; EORTC New Drug Development and Melanoma Groups. Phase II study of E7070 in patients with metastatic melanoma. Ann Oncol. 2005 Jan;16(1):158-61. doi: 10.1093/annonc/mdi016.
Other Identifiers
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EORTC-16005
Identifier Type: -
Identifier Source: secondary_id
EORTC-18002
Identifier Type: -
Identifier Source: secondary_id
EISAI-E7070-E044-205
Identifier Type: -
Identifier Source: secondary_id
EORTC-16005-18002
Identifier Type: -
Identifier Source: org_study_id