Do not administer ABRAXANE therapy to patients who have baseline neutrophil counts of less than 1,500 cells/mm3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving ABRAXANE
[see Contraindications (4), Warnings and Precautions and Adverse Reactions (6.1, 6.2, 6.3)].
Note: An albumin form of paclitaxel may substantially affect a drug’s functional properties relative to those of drug in solution. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS.
ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) is an albumin-bound form of paclitaxel with a mean particle size of approximately 130 nanometers. ABRAXANE is supplied as a white to yellow, sterile, lyophilized powder for reconstitution with 20 mL of 0.9% Sodium Chloride Injection, USP prior to intravenous infusion. Each single-use vial contains 100 mg of paclitaxel and approximately 900 mg of human albumin. Each milliliter (mL) of reconstituted suspension contains 5 mg paclitaxel. ABRAXANE is free of solvents. The active agent in ABRAXANE® is paclitaxel, a natural product with antitumor activity. Paclitaxel is obtained from Taxus media.
ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
Published Studies Related to Abraxane (Paclitaxel)
Randomized, phase II, placebo-controlled, double-blind study with and without
enzastaurin in combination with paclitaxel and carboplatin as first-line
treatment followed by maintenance treatment in advanced ovarian cancer. 
diagnosed advanced ovarian cancer... CONCLUSION: The PCE combination increased PFS, but it was not significantly
Randomized trial of lapatinib versus placebo added to paclitaxel in the treatment
of human epidermal growth factor receptor 2-overexpressing metastatic breast
in patients with HER2-overexpressing metastatic breast cancer (MBC)... CONCLUSION: This trial demonstrated that lapatinib combined with paclitaxel
Final results of phase III SYMMETRY study: randomized, double-blind trial of
elesclomol plus paclitaxel versus paclitaxel alone as treatment for
chemotherapy-naive patients with advanced melanoma. 
with advanced melanoma... CONCLUSION: The addition of elesclomol to paclitaxel did not significantly
Phase III trial of carboplatin and paclitaxel with or without sorafenib in
metastatic melanoma. 
metastatic melanoma... CONCLUSION: Sorafenib does not improve OS when given in combination with CP for
A Phase II, randomized, double-blind study of zibotentan (ZD4054) in combination
with carboplatin/paclitaxel versus placebo in combination with
carboplatin/paclitaxel in patients with advanced ovarian cancer sensitive to
platinum-based chemotherapy (AGO-OVAR 2.14). 
xenograft models of human ovarian cancer... CONCLUSIONS: Zibotentan 10mg/day plus carboplatin and paclitaxel did not result
Clinical Trials Related to Abraxane (Paclitaxel)
Hepatic Arterial Infusion (HAI) of Abraxane [Active, not recruiting]
The goal of this clinical research study is find the highest tolerated dose of Abraxane
(nab-paclitaxel) that can be given directly into the liver of patients with advanced cancer
that has spread to the liver.
Phase I & II Trial of Intravesicular Abraxane for Treatment-refractory Bladder Cancer [Recruiting]
The intravesical treatment of bladder cancer with Abraxane is more desirable than other
taxanes due to its ability to be diluted in water and not lipid-based solutions allowing it
greater access to sites in the bladder. Thus, we are interested in investigating Abraxane's
safety, toxicity, and efficacy profile for the treatment of recurrent transitional cell
cancer of the urinary bladder in a combined phase I & II trial. The phase I trial is
designed as a dose-escalation study with cohorts of threes that will enroll a maximum of 18
patients. Dose increases will occur in groups of three patients, with each successive group
receiving an increased concentration of Abraxane intravesically. No dose increase will
occur until each member of the previous cohort has undergone the first instillation of the
medication without experiencing a dose-limiting toxicity (DLT). Any patient who experiences
a DLT will be removed from the trial and treated appropriately.
If one patient in the cohort experiences a DLT an additional three patients will be enrolled
and treated at that dose-level. If none of the additional three patients experience a DLT,
the next group of patients will be started on the next higher dose level.
If at any dose level, two or more patients experience a DLT the previous dose level will be
considered as the maximum tolerated dose (MTD). An additional three patients (for a total
of six patients) will then be treated at the MTD. If less than two patients experience a
DLT this dose level will be established as the MTD. The phase II aspect is designed in a
Simon II stage format in which to satisfy our study powering, the first stage there will be
10 patients enrolled. If there are 2 or more successful treatments in that group (negative
urine cytology and bladder biopsy after 6 months), then the first stage will pass the
rejection rule, and up to another 19 patients will be enrolled. If at any point in the
study, there have been a total of 6 or more successes, then the phase II aspect will be
considered a successful trial and the study will be completed at that point.
Phase I/II Trial of the Combination of Lenalidomide (Revlimid) and Nab-paclitaxel (Abraxane) in the Treatment of Relapsed/Refractory Multiple Myeloma [Recruiting]
The investigators will perform a phase I/II trial of Revlimid daily for 21 days and Abraxane
weekly for 3 weeks. Accrual will be on standard cohorts of 3 patients. Once the maximum
toxicity dose (MTD) is reached, the level below will be expanded to 25 patients for a pilot
phase II trial. All treatments will be performed until progression. Assessments will be
made at least at the 2, 4 and 6 month timepoints and monthly thereafter until progression.
The purpose of this research study is to determine how much of the combination of Revlimid
and Abraxane can be given safely and how well they work together against the cancer.
Currently, this trial is in the phase 1 stage.
Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers [Recruiting]
The goal of this clinical research study is to learn if adding abraxane (nab-paclitaxel) to
gemcitabine and cisplatin can help to control metastatic or unresectable biliary cancer. The
safety of this drug combination will also be studied.
Safety and Efficacy Study of Abraxane as Maintenance Treatment After Abraxane Plus Carboplatin in 1st Line Stage IIIB / IV Squamous Cell Non-small Cell Lung Cancer [Recruiting]
Reports of Suspected Abraxane (Paclitaxel) Side Effects
Febrile Neutropenia (24),
Decreased Appetite (21),
White Blood Cell Count Decreased (21), more >>
Page last updated: 2014-11-30