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

Phase 2
18 Years
Not Enrolling
Intraocular Melanoma

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Trial Information

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



- To evaluate the overall response rate of patients with unresectable, metastatic uveal
melanoma treated with paclitaxel albumin-stabilized nanoparticle formulation.


- To determine the median progression-free survival of patients treated with this

- 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.

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

- Peripheral neuropathy of > grade 2.

Type of Study:


Study Design:

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

Outcome Measure:

Overall response rate

Outcome Time Frame:

up to 1 year following last treatment

Safety Issue:


Principal Investigator

Thomas E. Olencki, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

August 2008

Completion Date:

Related Keywords:

  • Intraocular Melanoma
  • ciliary body and choroid melanoma, medium/large size
  • iris melanoma
  • metastatic intraocular melanoma
  • recurrent intraocular melanoma
  • extraocular extension melanoma
  • Melanoma
  • Uveal Neoplasms



Ohio State University Comprehensive Cancer CenterColumbus, Ohio