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

Intraocular Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738361
• Other study ID #: OSU-08076
• Secondary ID: NCI-2011-03176
• Status: Completed
• Phase: Phase 2
• First received: August 19, 2008
• Last updated: January 14, 2016
• Start date: August 2008
• Est. completion date: April 2013

Study information

• Verified date: January 2016
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: April 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Intraocular Melanoma
• Melanoma
• Uveal Neoplasms

Intervention

Drug:
• nab-paclitaxel
150 mg/m2 weekly for 3 of 4 weeks every 28 days.

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	Celgene Corporation, National Comprehensive Cancer Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	up to 1 year following last treatment, for a total of approximately 5 years	No
Secondary	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	No
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.	up to 1 year following last treatment, for a total of approximately 5 years	No

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