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

A Phase 2 Study Of Weekly Infusion Nab-paclitaxel (Paclitaxel Protein-bound Particles for Injectable Suspension) In Patients With Unresectable And Metastatic Uveal Melanoma

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.

Study Overview

• Status: Completed
• Conditions: Intraocular Melanoma
• Intervention / Treatment: Drug: nab-paclitaxel

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: Celgene Corporation; National Comprehensive Cancer Network
• Investigators: Principal Investigator: Thomas E. Olencki, DO, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• Jamesline

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (ACTUAL): July 1, 2012
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: August 19, 2008
• First Submitted That Met QC Criteria: August 19, 2008
• First Posted (ESTIMATE): August 20, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): February 12, 2016
• Last Update Submitted That Met QC Criteria: January 14, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: ciliary body and choroid melanoma, medium/large size; extraocular extension melanoma; iris melanoma; recurrent intraocular melanoma; metastatic intraocular melanoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: OSU-08076; NCI-2011-03176 (REGISTRY: Clinical Trials Reporting Program (CTRP))