Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed By Surgery
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2008
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
  Purpose

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
Drug Information available for: Paclitaxel
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: August 2008
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To evaluate the overall response rate of patients with unresectable, metastatic uveal melanoma treated with paclitaxel albumin-stabilized nanoparticle formulation.

Secondary

  • To determine the median progression-free survival of patients treated with this regimen.
  • To determine the overall survival of patients treated with this regimen.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed uveal melanoma

    • Unresectable, metastatic disease
  • Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as ≥ 10 mm by spiral CT scan
  • Brain metastasis allowed provided the following criteria are met:

    • Definitively treated with radiotherapy or surgical resection
    • Stable disease as demonstrated by repeat MRI or head CT scans 4 weeks after completion of definitive therapy
    • No requirement for decadron

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Life expectancy > 6 months
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL
  • Total bilirubin ≤ 1.5 mg/dL (indirect bilirubin ≤ 4.0 mg/dL for patients with Gilbert's disease)
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN (unless bone metastasis is present in the absence of liver metastasis)
  • Creatinine ≤ 1.8 mg/dL OR creatinine clearance > 50 mL/min
  • Calcium < 12 mg/dL (corrected for serum albumin)
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV-negative
  • Hepatitis B- or C-negative
  • No prior malignancy except for adequately treated basal cell carcinoma of the skin, in situ cervical cancer, or other cancer for which the patient has been disease free for 2 years
  • No serious infections or other major uncontrolled medical illnesses
  • No significant psychiatric illness that, in the opinion of the principal investigator, would preclude adequate informed consent or render study therapy unsafe
  • No peripheral neuropathy > grade 2

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No more than one prior systemic therapy
  • Prior taxanes allowed provided there is disease progression > 12 months after completion of treatment
  • More than 4 weeks since prior chemotherapy, radiotherapy, or surgery and recovered
  • At least 4 months since prior chemoembolization or embolization of the liver

    • Disease must be present outside the embolized region of the liver for evaluation
  • No other concurrent investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738361

Locations
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        
Sponsors and Collaborators
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Comprehensive Cancer Network
Investigators
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
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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
Study First Received: August 19, 2008
Last Updated: November 18, 2008
ClinicalTrials.gov Identifier: NCT00738361  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
ciliary body and choroid melanoma, medium/large size
iris melanoma
metastatic intraocular melanoma
recurrent intraocular melanoma
extraocular extension melanoma

Study placed in the following topic categories:
Ocular melanoma
Eye Neoplasms
Eye Diseases
Recurrence
Melanoma
Neuroendocrine Tumors
Melanoma of the choroid
Neuroectodermal Tumors
Uveal melanoma
Paclitaxel
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Intraocular melanoma
Neuroepithelioma
Nevus

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Nevi and Melanomas
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009