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

Metastatic Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00226473
• Other study ID #: ADO-MM-PAL8
• Status: Recruiting
• Phase: Phase 4
• First received: September 25, 2005
• Last updated: June 20, 2006
• Start date: September 2001
• Est. completion date: September 2005

Study information

• Verified date: September 2005
• Source: Dermatologic Cooperative Oncology Group
• Contact: Jens Ulrich, MD
• Phone: +49-391-6715428
• Email: jens.ulrich[@]medizin.uni-magdeburg.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma

Intervention

Drug:
• Cisplatin, Vindesine, Dacarbazine (drugs)

Locations

Country	Name	City	State
Germany	Dept. of Dermatology, Charité Berlin	Berlin
Germany	Dept. of Dermatology, Vivantes Clinics	Berlin
Germany	Dept. of Dermatology, Medical Center Buxtehude	Buxtehude	Niedersachsen
Germany	Dept. of Dermatology, Helios Clinic Erfurt	Erfurt	Thuringia
Germany	Dept. of Dermatology, University of Frankfurt	Frankfurt	Hessen
Germany	Dept. of Dermatology, Hildesheim	Hildesheim	Niedersachsen
Germany	Dept. of. Dermatology, University of Saarland, Homburg	Homburg	Saaland
Germany	Dept. of Dermatology, University of Jena	Jena	Thuringia
Germany	Dept. of Dermatology, University of Schleswig-Holstein	Kiel	Schleswig-Holstein
Germany	Dept. of Dermatology, University of Schleswig-Holstein, Campus Lübeck	Lübeck	Schleswig-Holstein
Germany	Dept. of Dermatology, University Otto von Guericke	Magdeburg	Saxony-Anhalt
Germany	Skin Cancer Unit, German Cancer Ressearch Center and Dept. of Dermatology, University Hospital of Mannheim	Mannheim	Baden-Württemberg
Germany	Dept. of Dermatology, University Hospital Tuebingen	Tuebingen	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Dermatologic Cooperative Oncology Group

Country where clinical trial is conducted

Germany, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

Glimelius B, Ekström K, Hoffman K, Graf W, Sjödén PO, Haglund U, Svensson C, Enander LK, Linné T, Sellström 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival
Secondary	Quality of life analysis
Secondary	Objective tumor response rate in study arm B
Secondary	Time to tumor progression
Secondary	Cost analysis