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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00738361
Other study ID # OSU-08076
Secondary ID NCI-2011-03176
Status Completed
Phase Phase 2
First received August 19, 2008
Last updated January 14, 2016
Start date August 2008
Est. completion date April 2013

Study information

Verified date January 2016
Source Ohio State University Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
nab-paclitaxel
150 mg/m2 weekly for 3 of 4 weeks every 28 days.

Locations

Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

Sponsors (3)

Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center Celgene Corporation, National Comprehensive Cancer Network

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Response Rate Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. up to 1 year following last treatment, for a total of approximately 5 years No
Secondary Progression-free Survival Median progression free survival (PFS) in patients with metastatic uveal melanoma who received nab-paclitaxel up to 1 year following last treatment, for a total of approximately 5 years No
Secondary Overall Survival Overall Survival is defined as the time from the start of treatment (study day 1) until death to the date of his or her death. If the subject has not died, survival time will be censored on last date the subject was known to be alive. up to 1 year following last treatment, for a total of approximately 5 years No
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Completed NCT00952939 - Study of Tumor Samples in Patients Undergoing Radiation Therapy or Surgery For Primary Melanoma of the Eye N/A
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Completed NCT00089219 - Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma Phase 1/Phase 2
Completed NCT00445965 - Iodine I 131 Monoclonal Antibody 3F8 in Treating Patients With Central Nervous System Cancer or Leptomeningeal Cancer Phase 2
Completed NCT00243061 - AZD2171 in Treating Patients With Recurrent or Stage IV Melanoma Phase 2
Terminated NCT00110123 - Intravenous or Hepatic Arterial Infusion of Fotemustine in Treating Patients With Unresectable Liver Metastases From Eye Melanoma Phase 3
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