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

• ClinicalTrials.gov Identifier: NCT00738361
• Recruitment Status: Completed
• First Posted: August 20, 2008
• Results First Posted: February 12, 2016
• Last Update Posted: February 12, 2016
• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: National Comprehensive Cancer Network; Celgene Corporation
• Information provided by (Responsible Party): Thomas Olencki, Ohio State University Comprehensive Cancer Center

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 (Clinical Trial)
• 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: August 2008
• Actual Primary Completion Date: July 2012
• Actual Study Completion Date: April 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Ohio

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

More Information

Additional Information:

Jamesline 

• 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 ( Registry Identifier: Clinical Trials Reporting Program (CTRP) )
• First Posted: August 20, 2008
• Results First Posted: February 12, 2016
• Last Update Posted: February 12, 2016
• Last Verified: January 2016

Keywords provided by Thomas Olencki, 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; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Paclitaxel; Albumin-Bound Paclitaxel; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action