Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed By Surgery
Primary Purpose
Intraocular Melanoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
nab-paclitaxel
Sponsored by

About this trial
This is an interventional treatment trial for Intraocular Melanoma focused on measuring ciliary body and choroid melanoma, medium/large size, iris melanoma, metastatic intraocular melanoma, recurrent intraocular melanoma, extraocular extension melanoma
Eligibility 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.
Sites / Locations
- Ohio State University Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
nab-paclitaxel
Arm Description
Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Progression-free Survival
Median progression free survival (PFS) in patients with metastatic uveal melanoma who received nab-paclitaxel
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.
Full Information
NCT ID
NCT00738361
First Posted
August 19, 2008
Last Updated
January 14, 2016
Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Comprehensive Cancer Network, Celgene Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00738361
Brief Title
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed By Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Comprehensive Cancer Network, Celgene Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraocular Melanoma
Keywords
ciliary body and choroid melanoma, medium/large size, iris melanoma, metastatic intraocular melanoma, recurrent intraocular melanoma, extraocular extension melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nab-paclitaxel
Arm Type
Experimental
Arm Description
Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
Intervention Type
Drug
Intervention Name(s)
nab-paclitaxel
Other Intervention Name(s)
Abraxane, paclitaxel protein-bound particles for injectable suspension
Intervention Description
150 mg/m2 weekly for 3 of 4 weeks every 28 days.
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
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.
Time Frame
up to 1 year following last treatment, for a total of approximately 5 years
Secondary Outcome Measure Information:
Title
Progression-free Survival
Description
Median progression free survival (PFS) in patients with metastatic uveal melanoma who received nab-paclitaxel
Time Frame
up to 1 year following last treatment, for a total of approximately 5 years
Title
Overall Survival
Description
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.
Time Frame
up to 1 year following last treatment, for a total of approximately 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas E. Olencki, DO
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Links:
URL
http://cancer.osu.edu
Description
Jamesline
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Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed By Surgery
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