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Sponsors and Collaborators: |
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute National Cancer Institute (NCI) National Comprehensive Cancer Network |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00738361 |
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with metastatic melanoma of the eye that cannot be removed by surgery.
Condition | Intervention | Phase |
Intraocular Melanoma |
Drug: paclitaxel albumin-stabilized nanoparticle formulation |
Phase II |
Genetics Home Reference related topics: | retinoblastoma |
MedlinePlus related topics: | Cancer Melanoma |
ChemIDplus related topics: | Paclitaxel |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase 2 Study Of Weekly Infusion Nab-Paclitaxel (Paclitaxel Protein-Bound Particles for Injectable Suspension) In Patients With Unresectable And Metastatic Uveal Melanoma |
Estimated Enrollment: | 25 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 8 weeks for 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed uveal melanoma
Brain metastasis allowed provided the following criteria are met:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
At least 4 months since prior chemoembolization or embolization of the liver
United States, Ohio | |||||
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Recruiting | ||||
Columbus, Ohio, United States, 43210 | |||||
Contact: Thomas E. Olencki, DO 866-627-7616 |
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
National Cancer Institute (NCI) |
National Comprehensive Cancer Network |
Principal Investigator: | Thomas E. Olencki, DO | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Study Chair: | Thomas E. Olencki, DO | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Responsible Party: | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center ( Thomas E. Olencki ) |
Study ID Numbers: | CDR0000612312, OSU-08076, OSU-2008C0075, NCCN-AO7 |
First Received: | August 19, 2008 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00738361 |
Health Authority: | Unspecified |
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