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
18 Years
N/A
Both
Ocular Melanoma
Trial Information
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
Treatment of patients with metastatic ocular melanoma with combination chemotherapy
Gemcitabine and Treosulfan versus monotherapy with Treosulfan as first-line chemotherapy.
Inclusion Criteria:
- Metastatic ocular melanoma
Exclusion Criteria:
- Prior treatment with chemotherapy
- Active 2nd malignancy
- Cerebral metastasis
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determination of efficacy according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Principal Investigator
Ulrich Keilholz, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Charité Campus Benjamin Franklin Berlin
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
Haema CBF AHM UK/AS 04
NCT ID:
NCT00168870
Start Date:
February 2003
Completion Date:
Related Keywords:
- Ocular Melanoma
- metastatic ocular melanoma
- Melanoma
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