Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy in Metastasized Malignant Melanoma

Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy (CVD-Protocol) in the Second-Line Therapy of Distant Metastasized Malignant Melanoma

The purpose of this multicenter study is to examine whether the proposed randomized treatment regime results in a significantly longer survival time and higher quality of life than any additionally applied multiple chemotherapy according to the CVD- scheme. So far neither established treatment regimes nor reliable data exist for the second-line chemotherapy of metastatic malignant melanoma. Patients are therefore mostly treated with single or multiple chemotherapeutics or/and immunomodulatory therapeutics. These regimes however imply often not only a higher toxicity but show rarely a response rate higher than 10%.

Study Overview

• Status: Unknown
• Conditions: Metastatic Melanoma
• Intervention / Treatment: Drug: Cisplatin, Vindesine, Dacarbazine (drugs)

• Study Type: Interventional
• Enrollment: 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, D-10098
    • Recruiting
    • Dept. of Dermatology, Charité Berlin
    • Contact: Uwe Trefzer, MD; Phone Number: +49-30-450518063; Email: uwe.trefzer@charite.de
    • Contact: Maja Hofmann, MD; Phone Number: +49-30-450518063; Email: maja.hofmann@charite.de
    • Principal Investigator: Uwe Trefzer, MD
  • Berlin, Germany, D-12351
    • Recruiting
    • Dept. of Dermatology, Vivantes Clinics
    • Contact: Peter Kohl, MD; Phone Number: +49-30-60043601; Email: p.kohl@vivantes.de
    • Principal Investigator: Peter Kohl, MD
  • Baden-Württemberg
    • Mannheim, Baden-Württemberg, Germany, D-68167
      • Recruiting
      • Skin Cancer Unit, German Cancer Ressearch Center and Dept. of Dermatology, University Hospital of Mannheim
      • Principal Investigator: Dirk Schadendorf, MD
      • Contact: Dirk Schadendorf, MD; Phone Number: +49-621-3832127; Email: d.schadendorf@dkfz.de
    • Tuebingen, Baden-Württemberg, Germany, D-72076
      • Recruiting
      • Dept. of Dermatology, University Hospital Tuebingen
      • Contact: Claus Garbe, MD; Phone Number: +49-7071-2980872; Email: studienzentrum-derm-onko@med.uni-tuebingen.de
      • Principal Investigator: Claus Garbe, MD
  • Hessen
    • Frankfurt, Hessen, Germany, D-60590
      • Recruiting
      • Dept. of Dermatology, University of Frankfurt
      • Contact: Konstanze Spieth, MD; Phone Number: +49-69-6301-5311; Email: konstanze.spieth@kgu.de
      • Principal Investigator: Konstanze Spieth, MD
  • Niedersachsen
    • Buxtehude, Niedersachsen, Germany, D-21641
      • Recruiting
      • Dept. of Dermatology, Medical Center Buxtehude
      • Contact: Peter Mohr, MD; Phone Number: +49-4161-7036297; Email: mohrpe@cs.com
      • Principal Investigator: Peter Mohr, MD
    • Hildesheim, Niedersachsen, Germany, D-31134
      • Recruiting
      • Dept. of Dermatology, Hildesheim
      • Contact: Michael Tronnier, MD; Phone Number: +49-05121-894821
      • Principal Investigator: Michael Tronnier, MD
  • Saaland
    • Homburg, Saaland, Germany, D-66421
      • Recruiting
      • Dept. of. Dermatology, University of Saarland, Homburg
      • Contact: Wolfgang Tilgen, MD; Phone Number: +49-6841-3800; Email: hawtil@med-rz-sb.de
      • Sub-Investigator: Dorothea Tadler, MD
  • Saxony-Anhalt
    • Magdeburg, Saxony-Anhalt, Germany, D-39120
      • Recruiting
      • Dept. of Dermatology, University Otto von Guericke
      • Contact: Jens Ulrich, MD; Phone Number: +49-391-6715428; Email: jens.ulrich@medizin.uni-magdeburg.de
      • Contact: Vassiliki Bekou, MD; Phone Number: +49-391-6715264; Email: vassiliki.bekou@medizin.uni-magdeburg.de
      • Sub-Investigator: Vassiliki Bekou, MD
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, D-24105
      • Recruiting
      • Dept. of Dermatology, University of Schleswig-Holstein
      • Contact: Axel Hauschild, MD; Phone Number: +49-431-596-1613; Email: ahauschild@dermatology.uni.kiel.de
      • Principal Investigator: Axel Hauschild, MD
    • Lübeck, Schleswig-Holstein, Germany, D-23538
      • Recruiting
      • Dept. of Dermatology, University of Schleswig-Holstein, Campus Lübeck
      • Contact: Sven Krengel, MD; Phone Number: +49-451-5002517; Email: svenkrengel@gm.net
      • Principal Investigator: Sven Krengel, MD
  • Thuringia
    • Erfurt, Thuringia, Germany, 99012
      • Recruiting
      • Dept. of Dermatology, Helios Clinic Erfurt
      • Contact: Ruthild Linse, MD; Phone Number: +49-361-7814300
      • Principal Investigator: Ruthild Linse, MD
      • Sub-Investigator: Yvonne Kellner, MD
    • Jena, Thuringia, Germany, D-07740
      • Recruiting
      • Dept. of Dermatology, University of Jena
      • Contact: Martin Kaatz, MD; Phone Number: +49-3641-937302; Email: kaatz@derma.uni-jena.de
      • Principal Investigator: Martin Kaatz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• histological diagnosis of metastatic melanoma (stage IV)
• progressive disease after first-line chemotherapy or immuno-chemotherapy
• Karnofsky-index > 60%
• informed consent

Exclusion Criteria:

• Uvea melanoma
• another primary malignancy except basal cell carcinoma or cervical carcinoma in situ
• severe and/or uncontrolled medical disease (diabetes mellitus, cardiac insufficiency)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival

Secondary Outcome Measures

Outcome Measure
Time to tumor progression
Quality of life analysis
Objective tumor response rate in study arm B
Cost analysis

Collaborators and Investigators

• Sponsor: Dermatologic Cooperative Oncology Group
• Investigators: Principal Investigator: Jens Ulrich, MD, Dept. of Dermatology, University Otto von Guericke, Leipziger Strasse 44, D-39120 Magdeburg, Germany; Principal Investigator: Axel Hauschild, MD, Dept. of Dermatology, University of Kiel, Schittenhelmstrasse 5, D-24105 Kiel, Germany; Study Director: Peter Mohr, MD, Dept. of Dermatology, Medical Center Buxtehude, Krankenhausstrasse 1, D-21614 Buxtehude, Germany

Publications and helpful links

General Publications

• Glimelius B, Ekstrom K, Hoffman K, Graf W, Sjoden PO, Haglund U, Svensson C, Enander LK, Linne T, Sellstrom H, Heuman R. Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer. Ann Oncol. 1997 Feb;8(2):163-8. doi: 10.1023/a:1008243606668.
• Chapman PB, Einhorn LH, Meyers ML, Saxman S, Destro AN, Panageas KS, Begg CB, Agarwala SS, Schuchter LM, Ernstoff MS, Houghton AN, Kirkwood JM. Phase III multicenter randomized trial of the Dartmouth regimen versus dacarbazine in patients with metastatic melanoma. J Clin Oncol. 1999 Sep;17(9):2745-51. doi: 10.1200/JCO.1999.17.9.2745.
• Creagan ET, Suman VJ, Dalton RJ, Pitot HC, Long HJ, Veeder MH, Vukov AM, Rowland KM, Krook JE, Michalak JC. Phase III clinical trial of the combination of cisplatin, dacarbazine, and carmustine with or without tamoxifen in patients with advanced malignant melanoma. J Clin Oncol. 1999 Jun;17(6):1884-90. doi: 10.1200/JCO.1999.17.6.1884.
• Cure H, Souteyrand P, Ouabdesselam R, Roche H, Ravaud A, D'incan M, Viens P, Fargeot P, Lentz MA, Fumoleau P, Hanauske A, Chollet P. Results of a phase II trial with cystemustine at 90 mg/m(2) as a first- or second-line treatment in advanced malignant melanoma: a trial of the EORTC Clinical Studies Group. Melanoma Res. 1999 Dec;9(6):607-10. doi: 10.1097/00008390-199912000-00011.
• Hauschild A, Garbe C, Stolz W, Ellwanger U, Seiter S, Dummer R, Ugurel S, Sebastian G, Nashan D, Linse R, Achtelik W, Mohr P, Kaufmann R, Fey M, Ulrich J, Tilgen W. Dacarbazine and interferon alpha with or without interleukin 2 in metastatic melanoma: a randomized phase III multicentre trial of the Dermatologic Cooperative Oncology Group (DeCOG). Br J Cancer. 2001 Apr 20;84(8):1036-42. doi: 10.1054/bjoc.2001.1731.
• Propper DJ, Levitt NC, O'Byrne K, Braybrooke JP, Talbot DC, Ganesan TS, Thompson CH, Rajagopalan B, Littlewood TJ, Dixon RM, Harris AL. Phase II study of the oxygen saturation curve left shifting agent BW12C in combination with the hypoxia activated drug mitomycin C in advanced colorectal cancer. Br J Cancer. 2000 Jun;82(11):1776-82. doi: 10.1054/bjoc.2000.1138.
• Thongprasert S, Sanguanmitra P, Juthapan W, Clinch J. Relationship between quality of life and clinical outcomes in advanced non-small cell lung cancer: best supportive care (BSC) versus BSC plus chemotherapy. Lung Cancer. 1999 Apr;24(1):17-24. doi: 10.1016/s0169-5002(99)00017-3.

Study record dates

Study Major Dates

• Study Start: September 1, 2001
• Study Completion: September 1, 2005

Study Registration Dates

• First Submitted: September 25, 2005
• First Submitted That Met QC Criteria: September 25, 2005
• First Posted (Estimate): September 27, 2005

Study Record Updates

• Last Update Posted (Estimate): June 21, 2006
• Last Update Submitted That Met QC Criteria: June 20, 2006
• Last Verified: September 1, 2005

More Information

Terms related to this study

• Keywords: Chemotherapy; best supportive care; Metastasis; malignant Melanoma; standard palliative care
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neoplastic Processes; Neuroendocrine Tumors; Nevi and Melanomas; Neoplasm Metastasis; Melanoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Antineoplastic Agents, Phytogenic; Cisplatin; Dacarbazine; Vindesine
• Other Study ID Numbers: ADO-MM-PAL8