Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy in Metastasized Malignant Melanoma - Full Text View

Purpose

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%.

Condition	Intervention	Phase
Metastatic Melanoma	Drug: Cisplatin, Vindesine, Dacarbazine (drugs)	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy (CVD-Protocol) in the Second-Line Therapy of Distant Metastasized Malignant Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma Palliative Care

Drug Information available for: Dacarbazine Cisplatin

U.S. FDA Resources

Further study details as provided by Dermatologic Cooperative Oncology Group:

Primary Outcome Measures:

Overall survival

Secondary Outcome Measures:

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

Estimated Enrollment:	200
Study Start Date:	September 2001
Estimated Study Completion Date:	September 2005

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00226473

Contacts

Contact: Jens Ulrich, MD

+49-391-6715428

jens.ulrich@medizin.uni-magdeburg.de

Locations

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

Sponsors and Collaborators

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

More Information

Publications:

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.

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.

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.

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.

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.

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.

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.

ClinicalTrials.gov Identifier:	NCT00226473 History of Changes
Other Study ID Numbers:	ADO-MM-PAL8
Study First Received:	September 25, 2005
Last Updated:	June 20, 2006
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dermatologic Cooperative Oncology Group:

malignant Melanoma
Chemotherapy
Metastasis
standard palliative care
best supportive care

Additional relevant MeSH terms:

Melanoma
Neoplasm Metastasis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
Cisplatin
Dacarbazine

Vindesine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on May 16, 2013