Clinical trial NCT00738361: Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed By Surgery
Official title: A Phase 2 Study Of Weekly Infusion Nab-paclitaxel (Paclitaxel Protein-bound Particles for Injectable Suspension) In Patients With Unresectable And Metastatic Uveal Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intraocular Melanoma
Keywords: ciliary body and choroid melanoma, medium/large size
iris melanoma
metastatic intraocular melanoma
recurrent intraocular melanoma
extraocular extension melanoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Comprehensive Cancer Network
name: Celgene Corporation
First posted: 2008-08-20
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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 \<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.

Primary outcomes:
measure: Overall Response Rate
timeFrame: up to 1 year following last treatment, for a total of approximately 5 years
Secondary outcomes:
measure: Progression-free Survival
timeFrame: up to 1 year following last treatment, for a total of approximately 5 years
measure: Overall Survival
timeFrame: up to 1 year following last treatment, for a total of approximately 5 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Thomas E. Olencki, DO
role: PRINCIPAL_INVESTIGATOR
References: