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 range18 Years – 120 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.
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…