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

• Sponsor: Ohio State University Comprehensive Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00738361
• Collaborator: National Comprehensive Cancer Network (Other), Celgene Corporation (Industry)
• Enrollment: 4
• Location: 1
• Arm: 1
• Duration (Months): 56
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Intraocular Melanoma	Drug: nab-paclitaxel	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Overall Response Rate [up to 1 year following last treatment, for a total of approximately 5 years]

   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

1. Progression-free Survival [up to 1 year following last treatment, for a total of approximately 5 years]

   Median progression free survival (PFS) in patients with metastatic uveal melanoma who received nab-paclitaxel

2. Overall Survival [up to 1 year following last treatment, for a total of approximately 5 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Jamesline

Publications

None provided.

• Responsible Party: Thomas Olencki, Principal Investigator, Ohio State University Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT00738361
• Other Study ID Numbers: OSU-08076; NCI-2011-03176
• First Posted: Aug 20, 2008
• Last Update Posted: Feb 12, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Thomas Olencki, Principal Investigator, 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; Paclitaxel; Albumin-Bound Paclitaxel

Study Results

Participant Flow

Arm/Group Title	Nab-paclitaxel
Arm/Group Description	Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
Period Title: Overall Study
STARTED	4
COMPLETED	4
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	NAb-paclitaxel
Arm/Group Description	Nab-paclitaxel will be administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
Overall Participants	4
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 50%
>=65 years	2 50%
Sex: Female, Male (Count of Participants)
Female	2 50%
Male	2 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	4 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	4 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	4 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nab-paclitaxel
Arm/Group Description	Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days. nab-paclitaxel: 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
Measure Participants	4
Number [patients]	0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

all patients progressed at the time of first scan

Arm/Group Title	Nab-paclitaxel
Arm/Group Description	Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
Measure Participants	4
Median (95% Confidence Interval) [months]	6.2

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nab-paclitaxel
Arm/Group Description	Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
Measure Participants	4
Mean (Standard Error) [months]	6.1833 (0.8369)

Adverse Events

Adverse Event Reporting Description	The NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 was utilized for Adverse Event (AE) reporting
Arm/Group Title	NAb-paclitaxel
Arm/Group Description	Nab-paclitaxel will be administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.
All Cause Mortality
	NAb-paclitaxel
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	NAb-paclitaxel
	Affected / at Risk (%)	# Events
Total	0/4 (0%)
Other (Not Including Serious) Adverse Events
	NAb-paclitaxel
	Affected / at Risk (%)	# Events
Total	4/4 (100%)
Blood and lymphatic system disorders
Hemoglobin	3/4 (75%)	9
Leukocytes (total WBC)	4/4 (100%)	27
Venous insuffiency	1/4 (25%)	1
Lymphopenia	2/4 (50%)	13
Endocrine disorders
Hypothyroidism	1/4 (25%)	1
Gastrointestinal disorders
Constipation	2/4 (50%)	3
Diarrhea	3/4 (75%)	8
Dry mouth/salivary gland (xerostomia)	1/4 (25%)	1
Flatulence	1/4 (25%)	1
Hemorrhage	1/4 (25%)	1
Nausea	3/4 (75%)	6
General disorders
Edema: limb	1/4 (25%)	2
Fatigue	4/4 (100%)	10
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	1/4 (25%)	1
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)	2/4 (50%)	2
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils	1/4 (25%)	1
Infection with normal ANC or Grade 1 or 2 neutrophils	1/4 (25%)	2
Infection with normal ANC or Grade 1 or 2 neutrophils	2/4 (50%)	4
Infection with Normal ANC or Grade 1 or 2 Neutrophils	1/4 (25%)	2
Infection with normal ANC or Grade 1 or 2 Neutrophils	1/4 (25%)	2
Investigations
Creatinine	1/4 (25%)	6
Metabolism and nutrition disorders
Anorexia	2/4 (50%)	2
Hypocalcemia	2/4 (50%)	5
Alanine Aminotransferase (ALT)	3/4 (75%)	9
Aspartate aminotransferase (AST)	4/4 (100%)	8
Nervous system disorders
Dizziness	1/4 (25%)	1
Dizziness	1/4 (25%)	2
Sensory Neuropathy	3/4 (75%)	5
Psychiatric disorders
Insomnia	1/4 (25%)	1
Reproductive system and breast disorders
Hemorrhage	1/4 (25%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)	1/4 (25%)	2
Hemorrhage, pulmonary/upper respiratory - Nose	2/4 (50%)	2
Skin and subcutaneous tissue disorders
Dermatology Skin	3/4 (75%)	7
Alopecia	3/4 (75%)	5
Vascular disorders
Hypotension	2/4 (50%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.