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Sponsors and Collaborators: |
University of Wuerzburg Hiege-Stiftung gegen Hautkrebs medac GmbH DCS Innovative Diagnostik Systeme |
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Information provided by: | University of Wuerzburg |
ClinicalTrials.gov Identifier: | NCT00779714 |
This phase III trial is aimed to investigate the efficacy of an individualized, sensitivity-directed combination chemotherapy in comparison to the standard regimen DTIC.
Two question are aimed to be answered by this study:
Condition | Intervention | Phase |
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Melanoma |
Drug: DTIC (dacarbazine) Drug: paclitaxel + cisplatin Drug: treosulfan + cytarabine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Prospectively Randomized Phase III Study of an Individualized Sensitivity-Directed Combination Chemotherapy Versus DTIC as First-Line Treatment in Stage IV Metastatic Melanoma |
Estimated Enrollment: | 360 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | April 2013 |
Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A (individualized combined chemotherapy): Experimental |
Drug: paclitaxel + cisplatin
paclitaxel 200 mg/m2 cisplatin 50 mg/m2 d1 every 21 days
Drug: treosulfan + cytarabine
treosulfan 2500 mg/m2, d2 cytarabine 100 mg/m2, d1-3 every 21 days
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B (DTIC monochemotherapy): Active Comparator |
Drug: DTIC (dacarbazine)
1000 mg/m2, d1 every 21 days
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Melanoma is a cutaneous neoplasm known for its high aggressiveness, its early dissemination of metastases, and its poor prognosis once metastasized. Chemotherapy with dacarbacine (DTIC) is widely accepted as the standard treatment in metastatic melanoma, with reported response rates of about 10%. This poor outcome is assumed to be due to a high chemoresistance intrinsic to melanoma cells. However, other therapeutic options like polychemotherapy, biochemotherapy, immunotherapy as well as targeted agents did not yet prove to be superior to DTIC in multicenter randomized studies.
Therefore, chemotherapy still is considered as the main therapeutic option in advanced metastatic melanoma, and a number of non-standard chemotherapeutics have been tested in small pilot studies to improve treatment efficacy.
Even though complete remissions of metastatic lesions could only be observed in a few patients, these observations indicate a subgroup of patients exhibiting high sensitivity to certain anticancer drugs. An in vitro ATP-based chemosensitivity assay has been shown to differentiate between chemosensitive and chemoresistant melanoma patients. A phase-II-study testing this assay in 53 metastatic melanoma patients followed by a sensitivity-directed individualized chemotherapy demonstrated, that the chemosensitivity profile of an individual patient, reflected by the best individual chemosensitivity index (BICSI), correlated with therapy outcome in terms of therapy response and patient overall survival (Ugurel S: Clin Cancer Res 2006). Interestingly, a surprisingly high proportion of about 2/5 of the investigated patient cohort were classified as chemosensitive, the remaining 3/5 were classified as chemoresistant. Objective response was 36.4% in chemosensitive patients compared to 16.1% in chemoresistant patients (p=0.114); progression arrest (CR+PR+SD) was 59.1% versus 22.6% (p=0.01). Chemosensitive patients showed an increased overall survival of 14.6 months compared to 7.4 months in chemoresistant patients (p=0.041).
These encouraging results prompted the initiation of this randomized phase-III-trial investigating an individualized sensitivity-directed combination chemotherapy compared to the current standard treatment DTIC, as first-line treatment in metastatic melanoma. The therapeutics for chemosensitivity testing and treatment of patients were chosen considering the results of the phase-II-trial (paclitaxel+cisplatinum, treosulfan+cytarabine).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate hematological, renal and liver function as defined by the following laboratory values performed within 14 days prior to randomisation:
Exclusion Criteria:
Contact: Selma Ugurel, Prof. (MD) | 0049931201 ext 26118 | Ugurel_S@klinik.uni-wuerzburg.de |
Germany | |
Dept of Dermatology, University of Aachen | Recruiting |
Aachen, Germany, 52074 | |
Principal Investigator: Hans F Merk, Prof. (MD) | |
Dept of Dermatology, University of Berlin Charite | Recruiting |
Berlin, Germany, 10117 | |
Principal Investigator: Uwe Trefzer, PD (MD) | |
Dept of Dermatology, University of Bochum | Recruiting |
Bochum, Germany, 44791 | |
Principal Investigator: Norbert Brockmeyer, Prof. (MD) | |
Medizinisches Zentrum Bonn Friedensplatz | Recruiting |
Bonn, Germany, 53111 | |
Principal Investigator: Uwe Reinhold, Prof. (MD) | |
Dept of Dermatology, University of Essen | Recruiting |
Essen, Germany, 45147 | |
Principal Investigator: Dirk Schadendorf, Prof. (MD) | |
Dept of Dermatology, University of Frankfurt | Recruiting |
Frankfurt / Main, Germany, 60590 | |
Principal Investigator: Roland Kaufmann, Prof. (MD) | |
Dermatology, Klinikum Frankfurt/Oder | Recruiting |
Frankfurt/Oder, Germany, 15236 | |
Principal Investigator: Anett Milling, Dr. (MD) | |
Dept of Dermatology, University of Hannover | Recruiting |
Hannover, Germany, 30449 | |
Principal Investigator: Ralf Gutzmer, PD (MD) | |
Dept of Dermatology, Saarland University | Recruiting |
Homburg/Saar, Germany, 66421 | |
Principal Investigator: Knuth Rass, Dr. (MD) | |
Dept of Dermatology, University of Jena | Recruiting |
Jena, Germany, 07740 | |
Principal Investigator: Martin Kaatz, Dr. (MD) | |
Dept of Dermatology, University of Schleswig-Holstein Campus Kiel | Recruiting |
Kiel, Germany, 24105 | |
Principal Investigator: Axel Hauschild, Prof. (MD) | |
Dept of Dermatology, University of Wuerzburg | Recruiting |
Wuerzburg, Germany, 97080 | |
Principal Investigator: Selma Ugurel, Prof. (MD) | |
Dept of Dermatology, University of Schleswig-Holstein Campus Luebeck | Recruiting |
Luebeck, Germany, 23538 | |
Principal Investigator: Patrick Terheyden, Dr. (MD) | |
Dept of Dermatology, Univeristy of Magdeburg | Recruiting |
Magdeburg, Germany, 39120 | |
Principal Investigator: Martin Leverkus, Prof. (MD) | |
Dept of Dermatology, University of Mainz | Recruiting |
Mainz, Germany, 55131 | |
Principal Investigator: Carmen Loquai, Dr. (MD) | |
Dept of Dermatology, University of Mannheim | Recruiting |
Mannheim, Germany, 68167 | |
Principal Investigator: Jessica Hassel, Dr. (MD) | |
Dept of Dermatology, University of Marburg | Recruiting |
Marburg, Germany, 35033 | |
Principal Investigator: Michael Hertl, Prof. (MD) | |
Dept of Dermatology, University of Muenchen | Recruiting |
Muenchen, Germany, 80337 | |
Principal Investigator: Carola Berking, Prof. (MD) | |
Dept of Dermatology, University of Muenster | Recruiting |
Muenster, Germany, 48149 | |
Principal Investigator: Cord Sunderkoetter, Prof. (MD) | |
Dept of Medical Oncology, Fachklinik Hornheide | Recruiting |
Muenster, Germany, 48157 | |
Principal Investigator: Michael Fluck, Dr. (MD) | |
Dermatology, Klinikum Dorothea Christiane Erxleben | Recruiting |
Quedlinburg, Germany, 06484 | |
Principal Investigator: Jens Ulrich, PD (MD) | |
Dept of Dermatology, University of Tuebingen | Recruiting |
Tuebingen, Germany, 72086 | |
Principal Investigator: Claus Garbe, Prof. (MD) | |
Dermatology, Klinikum Ludwishafen | Recruiting |
Ludwigshafen, Germany, 67063 | |
Principal Investigator: Edgar Dippel, Prof. (MD) |
Study Chair: | Selma Ugurel, Prof. (MD) | Dept of Dermatology, University of Wuerzburg |
Responsible Party: | Dept of Dermatology, University of Wuerzburg ( Prof. Dr. med. Selma Ugurel ) |
Study ID Numbers: | 101.321-13/07, EudraCT Nr. 2008-001686-28 |
Study First Received: | October 22, 2008 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00779714 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
metastatic (AJCC stage IV) first-line chemotherapy ex-vivo chemosensitivity profiling evaluation of biomarkers |
Antimetabolites Anti-Infective Agents Dacarbazine Immunologic Factors Antimitotic Agents Immunosuppressive Agents Antiviral Agents Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Cisplatin Radiation-Sensitizing Agents |
Paclitaxel Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Tubulin Modulators Neuroepithelioma Antineoplastic Agents, Alkylating Nevus Treosulfan Antineoplastic Agents, Phytogenic Alkylating Agents Cytarabine |
Antimetabolites Anti-Infective Agents Dacarbazine Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Melanoma Cisplatin Neoplasms, Germ Cell and Embryonal Therapeutic Uses Nevi and Melanomas Alkylating Agents |
Cytarabine Neoplasms by Histologic Type Mitosis Modulators Antimitotic Agents Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Radiation-Sensitizing Agents Paclitaxel Tubulin Modulators Antineoplastic Agents, Alkylating Treosulfan |