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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03176 | Registry Identifier | Clinical Trials Reporting Program (CTRP) |
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| Name | Class |
|---|---|
| National Comprehensive Cancer Network | NETWORK |
| Celgene Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nab-paclitaxel | Experimental | Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nab-paclitaxel | Drug | 150 mg/m2 weekly for 3 of 4 weeks every 28 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Overall Survival |
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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:
Patients my have had up to one prior systemic therapy
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas E. Olencki, DO | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| Jamesline | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nab-paclitaxel | Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | NAb-paclitaxel | Nab-paclitaxel will be administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | patients | up to 1 year following last treatment, for a total of approximately 5 years |
|
|
| |||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Median progression free survival (PFS) in patients with metastatic uveal melanoma who received nab-paclitaxel | all patients progressed at the time of first scan | Posted | Median | 95% Confidence Interval | months | up to 1 year following last treatment, for a total of approximately 5 years |
|
| ||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Error | months | up to 1 year following last treatment, for a total of approximately 5 years |
|
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The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NAb-paclitaxel | Nab-paclitaxel will be administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days. | 0 | 4 | 4 | 4 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | CTCAE Version 3 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE Version 3 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE Version 3 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE Version 3 | Systematic Assessment |
| |
| Creatinine | Investigations | CTCAE Version 3 | Systematic Assessment |
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| Dermatology Skin | Skin and subcutaneous tissue disorders | CTCAE Version 3 | Systematic Assessment | chest lesion scalp sore mole changes |
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| Diarrhea | Gastrointestinal disorders | CTCAE Version 3 | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE Version 3 | Systematic Assessment |
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| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | CTCAE Version 3 | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE Version 3 | Systematic Assessment |
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| Edema: limb | General disorders | CTCAE Version 3 | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | CTCAE Version 3 | Systematic Assessment |
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| Fatigue | General disorders | CTCAE Version 3 | Systematic Assessment |
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| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | CTCAE Version 3 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | CTCAE Version 3 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | CTCAE Version 3 | Systematic Assessment |
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| Hemoglobin | Blood and lymphatic system disorders | CTCAE Version 3 | Systematic Assessment |
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| Hemorrhage | Gastrointestinal disorders | CTCAE Version 3 | Systematic Assessment | GI - Varices (rectal) |
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| Hemorrhage | Reproductive system and breast disorders | CTCAE Version 3 | Systematic Assessment | GU - Urinary NOS |
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| Hemorrhage, pulmonary/upper respiratory - Nose | Respiratory, thoracic and mediastinal disorders | CTCAE Version 3 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE Version 3 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils | Infections and infestations | CTCAE Version 3 | Systematic Assessment | Bladder |
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| Infection with normal ANC or Grade 1 or 2 neutrophils | Infections and infestations | CTCAE Version 3 | Systematic Assessment | Ungual (nails) |
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| Infection with normal ANC or Grade 1 or 2 neutrophils | Infections and infestations | CTCAE Version 3 | Systematic Assessment | Upper airway NOS |
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| Insomnia | Psychiatric disorders | CTCAE Version 3 | Systematic Assessment |
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| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAE Version 3 | Systematic Assessment |
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| Venous insuffiency | Blood and lymphatic system disorders | CTCAE Version 3 | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | CTCAE Version 3 | Systematic Assessment |
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| Alanine Aminotransferase (ALT) | Metabolism and nutrition disorders | CTCAE Version 3 | Systematic Assessment |
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| Aspartate aminotransferase (AST) | Metabolism and nutrition disorders | CTCAE Version 3 | Systematic Assessment |
| |
| Infection with Normal ANC or Grade 1 or 2 Neutrophils | Infections and infestations | CTCAE Version 3 | Systematic Assessment | Skin (cellulitis) |
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| Infection with normal ANC or Grade 1 or 2 Neutrophils | Infections and infestations | CTCAE Version 3 | Systematic Assessment | Urinary tract NOS and vagina |
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| Nausea | Gastrointestinal disorders | CTCAE Version 3 | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE Version 3 | Systematic Assessment |
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| Sensory Neuropathy | Nervous system disorders | CTCAE Version 3 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Olencki, D.O. | Ohio State University Comprehensive Cancer Center | 614-293-2886 | Thomas.Olencki@osumc.edu |
| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
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| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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