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

The Ohio State University

Status and phase

Completed

Phase 2

Conditions

Intraocular Melanoma

Treatments

Drug: nab-paclitaxel

Study type

Interventional

Funder types

Other

NETWORK

Industry

Identifiers

NCT00738361

NCI-2011-03176 (Registry Identifier)

OSU-08076

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.