A Treatment Combination for Patients With Unresectable Stage III or Stage IV Melanoma
NCT ID: NCT00111007
Last Updated: 2014-10-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
270 participants
INTERVENTIONAL
2005-05-31
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Sorafenib (Nexavar, BAY43-9006)
Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die \[twice daily\]) on Study Days 2 to 19 + Paclitaxel (225 mg/m\^2 iv \[Intravenous\]) and Carboplatin (AUC \[area under the curve\] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
Sorafenib (Nexavar, BAY43-9006)
Sorafenib, 400 mg po (per os), 2 tablets (200 mg each) bid Study Days 2-19
Carboplatin/Paclitaxel
Paclitaxel (225 mg/m\^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1
Carboplatin/Paclitaxel (C/P)
Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m\^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
Carboplatin/Paclitaxel
Paclitaxel (225 mg/m\^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1
Placebo
Placebo, 2 tablets bid Study Days 2-19
Interventions
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Sorafenib (Nexavar, BAY43-9006)
Sorafenib, 400 mg po (per os), 2 tablets (200 mg each) bid Study Days 2-19
Carboplatin/Paclitaxel
Paclitaxel (225 mg/m\^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1
Placebo
Placebo, 2 tablets bid Study Days 2-19
Eligibility Criteria
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Inclusion Criteria
* Subjects with histologically or cytologically confirmed unresectable (Stage III) or metastatic (Stage IV) melanoma
* Subjects must have progressed after receiving at least one cycle of DTIC or TMZ containing regimen
* Subjects who have an ECOG PS of 0 or 1
* Measurable disease defined as at least one lesion that can be accurately and serially measured per the modified RECIST criteria
Exclusion Criteria
* Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta \[Noninvasive papillary carcinoma\], Tis \[Carcinoma in situ: "flat tumor"\]\& T1 \[Tumor invades subepithelial connective tissue\]) or any cancer curatively treated \< 5 years prior to study entry
* History of cardiac disease
* Known history of human immunodeficiency virus (HIV) infection
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Birmingham, Alabama, United States
Tucson, Arizona, United States
Los Angeles, California, United States
Aurora, Colorado, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Park Ridge, Illinois, United States
Louisville, Kentucky, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Montclair, New Jersey, United States
Buffalo, New York, United States
New York, New York, United States
Columbus, Ohio, United States
Pittsburgh, Pennsylvania, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Charlottesville, Virginia, United States
Seattle, Washington, United States
Camperdown, New South Wales, Australia
Warartah, New South Wales, Australia
Westmead, New South Wales, Australia
Brisbane, Queensland, Australia
East Melbourne, Victoria, Australia
Heidelberg, Victoria, Australia
Malvern, Victoria, Australia
Melbourne, Victoria, Australia
Nedlands, Western Australia, Australia
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Bordeaux, , France
Boulogne-Billancourt, , France
Brest, , France
Lyon, , France
Montpellier, , France
Paris, , France
Paris, , France
Villejuif, , France
Heidelberg, Baden-Wurttemberg, Germany
Mannheim, Baden-Wurttemberg, Germany
Tübingen, Baden-Wurttemberg, Germany
München, Bavaria, Germany
Frankfurt am Main, Hesse, Germany
Frankfurt am Main, Hesse, Germany
Essen, North Rhine-Westphalia, Germany
Trier, Rhineland-Palatinate, Germany
Homburg, Saarland, Germany
Kiel, Schleswig-Holstein, Germany
Berlin, State of Berlin, Germany
Amsterdam, , Netherlands
Rotterdam, , Netherlands
Utrecht, , Netherlands
Southampton, Hampshire, United Kingdom
Leicester, Leicestershire, United Kingdom
London, London, United Kingdom
London, London, United Kingdom
Manchester, Manchester, United Kingdom
Bebington, Merseyside, United Kingdom
Nottingham, Nottinghamshire, United Kingdom
Sutton, Surrey, United Kingdom
Leeds, West Yorkshire, United Kingdom
Swansea, , United Kingdom
Countries
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References
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Hauschild A, Agarwala SS, Trefzer U, Hogg D, Robert C, Hersey P, Eggermont A, Grabbe S, Gonzalez R, Gille J, Peschel C, Schadendorf D, Garbe C, O'Day S, Daud A, White JM, Xia C, Patel K, Kirkwood JM, Keilholz U. Results of a phase III, randomized, placebo-controlled study of sorafenib in combination with carboplatin and paclitaxel as second-line treatment in patients with unresectable stage III or stage IV melanoma. J Clin Oncol. 2009 Jun 10;27(17):2823-30. doi: 10.1200/JCO.2007.15.7636. Epub 2009 Apr 6.
Related Links
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Click here and search for information of Bayer products for Europe
Other Identifiers
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2005-000941-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
11718
Identifier Type: -
Identifier Source: org_study_id
NCT00262912
Identifier Type: -
Identifier Source: nct_alias
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