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Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed By Surgery

This study has been completed.
Sponsor:
Collaborators:
National Comprehensive Cancer Network
Celgene Corporation
Information provided by (Responsible Party):
Thomas Olencki, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00738361
First received: August 19, 2008
Last updated: January 14, 2016
Last verified: January 2016
  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: nab-paclitaxel
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: up to 1 year following last treatment, for a total of approximately 5 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Progression-free Survival [ Time Frame: up to 1 year following last treatment, for a total of approximately 5 years ] [ Designated as safety issue: No ]
    Median progression free survival (PFS) in patients with metastatic uveal melanoma who received nab-paclitaxel

  • Overall Survival [ Time Frame: up to 1 year following last treatment, for a total of approximately 5 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 4
Study Start Date: August 2008
Study Completion Date: April 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nab-paclitaxel
Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
Drug: nab-paclitaxel
150 mg/m2 weekly for 3 of 4 weeks every 28 days.
Other Names:
  • Abraxane
  • paclitaxel protein-bound particles for injectable suspension

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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed evidence of metastatic/ unresectable uveal melanoma
  • Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension and is ≥10 mm by spiral CT scan
  • 18 years or older
  • Eastern Cooperative Oncology Group(ECOG)performance status 0, or 1
  • No known HIV or Hepatitis B or C
  • Patients with brain metastasis are eligible for entry into the study
  • Patients must have normal organ/marrow function as defined below:

    • Absolute neutrophil count ≥ 1.5 x 109/L
    • Platelets ≥ 100,000 x 109/L
    • Hemoglobin ≥ 9.0 gm/100 ml
    • Total bilirubin ≤ 1.5. In patients with Gilbert's disease the indirect bilirubin must be less than or equal to 4.0.
    • AST and ALT ≤ 2.5x upper limit of normal
    • Alkaline phosphatase ≤ 2.5x upper limit of normal, unless bone metastases is present in the absence of liver metastasis
    • Creatinine ≤ 1.8 mg/ml or calculated creatinine clearance > 50 mg ml.
    • Calcium <12 mg/dl when corrected for levels of serum albumen
  • Patients my have had up to one prior systemic therapy

Exclusion Criteria:

  • Chemotherapy or radiotherapy within 4 weeks prior to entering the study or failure to recover from adverse events due to agents administered more than 4 weeks earlier.
  • May not be receiving any other simultaneous investigational agents
  • No prior malignancy except for adequately treated basal cell cancer, in situ cervical cancer or other cancer for which the patient has been disease free for 2 years.
  • Patients who have serious infections or other major uncontrolled medical illnesses.
  • Patients who have significant psychiatric illness who in the opinion of the principal investigator would prevent adequate informed consent or render therapy unsafe.
  • Patients who are pregnant. Female patients of child bearing potential must have a negative serum pregnancy test and use adequate contraception protection while on study.
  • Peripheral neuropathy of > grade 2.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738361

Locations
United States, Ohio
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Comprehensive Cancer Network
Celgene Corporation
Investigators
Principal Investigator: Thomas E. Olencki, DO Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
Responsible Party: Thomas Olencki, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00738361     History of Changes
Other Study ID Numbers: OSU-08076  NCI-2011-03176 
Study First Received: August 19, 2008
Results First Received: October 28, 2015
Last Updated: January 14, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
ciliary body and choroid melanoma, medium/large size
iris melanoma
metastatic intraocular melanoma
recurrent intraocular melanoma
extraocular extension melanoma

Additional relevant MeSH terms:
Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 26, 2016