Phase 2 N=4 Treatment

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

Intraocular Melanoma

Bottom Line

View on ClinicalTrials.gov: NCT00738361 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2016

Primary outcome: Primary: Overall Response Rate — 0 patients

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: nab-paclitaxel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ohio State University Comprehensive Cancer Center
Primary completion: Jul 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Response Rate	—	—
SECONDARY Progression-free Survival	6.2	—
SECONDARY Overall Survival	6.1833	—

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.

Eligibility 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 grade 2.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00738361). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.