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

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: Celgene Corporation; National Comprehensive Cancer Network
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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.