Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced or Refr… (NCT00499291) | Clinical Trial Compass
WithdrawnNot Applicable
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced or Refractory Solid Tumors
0Started 2006-09
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 clinical trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with advanced or refractory solid tumors.
Who can participate
Age range
18 Years – 120 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.
DISEASE CHARACTERISTICS:
* Patients must have an incurable advanced or refractory tumor amenable to treatment with paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel)
* Per the National Comprehensive Cancer Network, the following cancer sites have been shown to be responsive to taxane therapy:
* Prostate cancer
* Breast cancer
* Non-small cell lung cancer
* Bladder cancer
* Head and neck cancer
* Oral cancer
* Cervical cancer
* Ovarian cancer
* Endometrial cancer
* Esophageal cancer
* Gastric cancer
* Germ cell tumors
* Tumors of unknown primary
* Soft tissue sarcomas
* Small cell lung cancer
* Testicular cancer
* Upper genitourinary tract cancers
PATIENT CHARACTERISTICS:
* Patients must have performance status 0-2 by the ECOG scale
* Absolute neutrophil count ≥ 1,500/μL
* Platelet count ≥ 100,000/μL
* Hemoglobin ≥ 9 g/dL
* Bilirubin ≤ institutional upper limit of normal (ULN)
* ALT and AST ≤ 2.5 x ULN
* Alkaline phosphatase ≤ 2.5 x ULN (if bone metastasis is present in the absence of liver metastasis, alkaline phosphatase must be ≤ 5 x ULN)
* Creatinine ≤ 1.5 x ULN
* Patients must not have baseline sensory neuropathy ≥ grade 2
* Women must not be pregnant or breastfeeding
* Negative blood or urine pregnancy test
* Women of childbearing potential and sexually active males must agree to use an accepted and effective method of contraception
PRIOR CONCURRENT THERAPY:
* Prior treatmen…
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.