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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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