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

Completed · Phase 2

Conditions studied: Intraocular Melanoma

In brief

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.

Key facts

Study ID

NCT00738361

Run by

Ohio State University Comprehensive Cancer Center

People needed

4

Starts

2008-08-01

Expected to finish

2013-04-01

Last updated by the study team

2016-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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