Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Metastatic Melan… (NCT00738361) | Clinical Trial Compass
CompletedPhase 2
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed By Surgery
United States4 participantsStarted 2008-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…
What they're measuring
1
Overall Response Rate
Timeframe: up to 1 year following last treatment, for a total of approximately 5 years
Trial details
NCT IDNCT00738361
SponsorOhio State University Comprehensive Cancer Center