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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 10, 2001 | ||||||||
| Last Updated Date | July 23, 2008 | ||||||||
| Start Date ICMJE | February 2001 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00014625 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | E7070 in Treating Patients With Stage IV Melanoma | ||||||||
| Official Title ICMJE | Open Label Phase II Study Of E7070 In Patients With Metastatic Melanoma (Stage IV) | ||||||||
| 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. |
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| 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. |
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| Study Phase | Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment | ||||||||
| Condition ICMJE | Melanoma (Skin) | ||||||||
| Intervention ICMJE | Drug: indisulam | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Enrollment ICMJE | |||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Austria, Belgium, France, Germany, Italy, Norway, Portugal, Switzerland, United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00014625 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | CDR0000068573, EORTC-16005, EORTC-18002, EISAI-E7070-E044-205 | ||||||||
| Study Sponsor ICMJE | European Organization for Research and Treatment of Cancer | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||
| Verification Date | February 2005 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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