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NCT00168870 Clinical Trial

Study of Metastatic Ocular Melanoma

Ocular Melanoma Clinical Trial

Official title:
Randomized Phase II Study to Compare a Combination Therapy With Gemcitabine and Treosulfan Versus a Monotherapy as First-Line Chemotherapy for Patients With Metastatic Ocular Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00168870
Other study ID # Haema CBF AHM UK/AS 04
Secondary ID
Status Recruiting
Phase Phase 2
First received September 9, 2005
Last updated August 30, 2007
Start date February 2003

Study information
Verified date September 2006
Source Charite University, Berlin, Germany
Contact Ulrich Keilholz, MD
Phone +49-30-8445-3596
Email ulrich.keilholz@charite.de
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

This study evaluates treatment with combination versus monotherapy for patients with metastatic ocular melanoma.

Description:

Treatment of patients with metastatic ocular melanoma with combination chemotherapy Gemcitabine and Treosulfan versus monotherapy with Treosulfan as first-line chemotherapy.

Recruitment information / eligibility
Status Recruiting
Enrollment 48
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Metastatic ocular melanoma

Exclusion Criteria:

- Prior treatment with chemotherapy

- Active 2nd malignancy

- Cerebral metastasis

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Gemcitabine

• Treosulfan

Locations
Country Name City State
Germany Hematology & Oncology Charité CBF Berlin Berlin

Sponsors (1)
Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Determination of efficacy according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Secondary Time to progression
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