Study of Metastatic Ocular Melanoma

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00168870

Enrollment

Registered

2005-09-15

Start date

2003-02-28

Completion date

Unknown

Last updated

2007-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Melanoma

Keywords

metastatic ocular melanoma

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.

Interventions

DRUGGemcitabine

DRUGTreosulfan

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Metastatic ocular melanoma

Exclusion criteria

* Prior treatment with chemotherapy * Active 2nd malignancy * Cerebral metastasis

Design outcomes

Primary

Measure	Time frame
Determination of efficacy according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria	—

Secondary

Measure	Time frame
Time to progression	—

Countries

Germany

Contacts

Primary ContactUlrich Keilholz, MD

ulrich.keilholz@charite.de+49-30-8445-3596

Backup ContactAlexander Schmittel, MD

alexander.schmittel@charite.de+49-30-8445-3090

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026