Back to resultsStudy of Metastatic Ocular Melanoma
Primary Purpose
Ocular Melanoma
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Gemcitabine
Treosulfan
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Melanoma focused on measuring metastatic ocular melanoma
Eligibility Criteria
Inclusion Criteria: Metastatic ocular melanoma Exclusion Criteria: Prior treatment with chemotherapy Active 2nd malignancy Cerebral metastasis
Sites / Locations
- Hematology & Oncology Charité CBF BerlinRecruiting
Outcomes
Primary Outcome Measures
Determination of efficacy according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Secondary Outcome Measures
Time to progression
Full Information
NCT ID
NCT00168870
First Posted
September 9, 2005
Last Updated
August 30, 2007
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT00168870
Brief Title
Study of Metastatic Ocular Melanoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
5. Study Description
Brief Summary
This study evaluates treatment with combination versus monotherapy for patients with metastatic ocular melanoma.
Detailed Description
Treatment of patients with metastatic ocular melanoma with combination chemotherapy Gemcitabine and Treosulfan versus monotherapy with Treosulfan as first-line chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Melanoma
Keywords
metastatic ocular melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Type
Drug
Intervention Name(s)
Treosulfan
Primary Outcome Measure Information:
Title
Determination of efficacy according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Secondary Outcome Measure Information:
Title
Time to progression
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Metastatic ocular melanoma
Exclusion Criteria:
Prior treatment with chemotherapy
Active 2nd malignancy
Cerebral metastasis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ulrich Keilholz, MD
Phone
+49-30-8445-3596
Email
ulrich.keilholz@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Schmittel, MD
Phone
+49-30-8445-3090
Email
alexander.schmittel@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Keilholz, MD
Organizational Affiliation
Charité Campus Benjamin Franklin Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hematology & Oncology Charité CBF Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrich Keilholz, MD
Phone
+49-30-8445-3596
Email
ulrich.keilholz@charite.de
First Name & Middle Initial & Last Name & Degree
Alexander Schmittel, MD
Phone
+49-30-8445-3090
Email
alexander.schmittel@charite.de
First Name & Middle Initial & Last Name & Degree
Ulrich Keilholz, MD
12. IPD Sharing Statement
Learn more about this trial
Study of Metastatic Ocular Melanoma
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