ONXOL® (paclitaxel) Injection should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.
Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2-4% of patients receiving paclitaxel in clinical trials. Fatal reactions have occurred in patients despite premedication. All patients should be pretreated with corticosteroids, diphenhydramine, and H2 antagonists. (See “ DOSAGE AND ADMINISTRATION ” section). Patients who experience severe hypersensitivity reactions to paclitaxel should not be rechallenged with the drug.
ONXOL therapy should not be given to patients with solid tumors who have baseline neutrophil counts of less than 1,500 cells/mm3 and should not be given to patients with AIDS-related Kaposi’s sarcoma if the baseline neutrophil count is less than 1,000 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 ONXOL.
ONXOL® (paclitaxel) Injection is a clear colorless to slightly yellow viscous solution. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion.
ONXOL is indicated as subsequent therapy for the treatment of advanced carcinoma of the ovary.
ONXOL 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 Onxol (Paclitaxel)
Omega-3 fatty acids are protective against paclitaxel-induced peripheral
neuropathy: a randomized double-blind placebo controlled trial. 
proinflammatory cytokines involved in peripheral neuropathy... CONCLUSIONS: Omega-3 fatty acids may be an efficient neuroprotective agent for
BEAM: a randomized phase II study evaluating the activity of bevacizumab in
combination with carboplatin plus paclitaxel in patients with previously
untreated advanced melanoma. 
metastatic melanoma... CONCLUSION: The study did not meet the primary objective of statistically
Impact of Lesion Length and Vessel Size on Clinical Outcomes After Percutaneous Coronary Intervention With Everolimus- Versus Paclitaxel-Eluting Stents Pooled Analysis From the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) Randomized Trials. [2011.11]
OBJECTIVES: The aim of this study was to investigate the impact of reference vessel diameter (RVD) and lesion length (LL) on the relative safety and efficacy of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES). BACKGROUND: Lesion length and RVD are well-known predictors of adverse events after percutaneous coronary intervention... CONCLUSIONS: Patients with short lesions in large vessels have low rates of MACE at 2 years after treatment with either EES or PES. In higher-risk patients with long lesions and/or small vessels, EES results in significant improvements in both clinical safety and efficacy outcomes. (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions; NCT00180310; SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT00180479; SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT00307047; A Randomized Controlled Trial of Everolimus-eluting Stents and Paclitaxel-eluting Stents for Coronary Revascularization in Daily Practice: The COMPARE Trial; NCT01016041). Copyright (c) 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial. [2011.09.17]
BACKGROUND: Platinum-based doublet chemotherapy is recommended to treat advanced non-small-cell lung cancer (NSCLC) in fit, non-elderly adults, but monotherapy is recommended for patients older than 70 years. We compared a carboplatin and paclitaxel doublet chemotherapy regimen with monotherapy in elderly patients with advanced NSCLC... INTERPRETATION: Despite increased toxic effects, platinum-based doublet chemotherapy was associated with survival benefits compared with vinorelbine or gemcitabine monotherapy in elderly patients with NSCLC. We feel that the current treatment paradigm for these patients should be reconsidered. FUNDING: Intergroupe Francophone de Cancerologie Thoracique, Institut National du Cancer. Copyright (c) 2011 Elsevier Ltd. All rights reserved.
Cationic liposomal paclitaxel plus gemcitabine or gemcitabine alone in patients with advanced pancreatic cancer: a randomized controlled phase II trial. [2011.09.06]
BACKGROUND: Paclitaxel embedded in cationic liposomes (EndoTAG-1; ET) is an innovative agent targeting tumor endothelial cells. This randomized controlled phase II trial evaluated the safety and efficacy of ET in combination with gemcitabine (GEM) in advanced pancreatic cancer (PDAC)... CONCLUSIONS: Treatment of advanced PDAC with GEM + ET was generally well tolerated. GEM + ET showed beneficial survival and efficacy. A randomized phase III trial should confirm this positive trend.
Clinical Trials Related to Onxol (Paclitaxel)
Comparison of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) and Taxol® Pharmacokinetics in Patients With Advanced Cancer [Active, not recruiting]
In this study, Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) is being compared to
Taxol® to examine whether the paclitaxel in these 2 formulations undergoes similar processing
by the body. Safety and tolerability of LEP-ETU and Taxol will also be assessed. In this
study, each patient will receive one intravenous infusion of LEP-ETU or Taxol, followed 3
weeks later by an infusion of the other drug, at the same dose and infusion duration.
Multiple blood samples will be taken for analysis before, during, and after both drug
infusions. Upon completing these 2 Cycles of treatment, eligible patients may enroll in an
extension study (LEP-ETU-102B) to continue treatment with LEP-ETU.
LEP-ETU is a liposomal formulation of paclitaxel, a widely used anti-cancer drug. This
LEP-ETU formulation of paclitaxel is being developed to potentially reduce toxicities
associated with Taxol, by eliminating the drug formulation component polyoxyethylated castor
oil (CremophorÂ® EL). In LEP-ETU, paclitaxel is associated with liposomes, which are
microscopic membrane-like structures created from lipids (fats). Thus, the LEP-ETU
formulation could potentially have reduced toxicity, while maintaining or enhancing
Use of Nanoparticle Paclitaxel (ABI-007) for the Prevention of In-Stent Restenosis [Active, not recruiting]
The purpose of this study is to investigate the use of systemic intracoronary administration
of albumin-bound paclitaxel, ABI-007, for the prevention and reduction of restenosis
following de novo stenting or following angioplasty for in-stent restenosis.
Study of Dose-Dense Adriamycin Plus Cytoxan (AC) Followed by Either Abraxane or Taxol With Bevacizumab as Adjuvant Therapy for Patients With Breast Cancer [Active, not recruiting]
The primary objective of this study is to compare the safety of dose-dense Abraxane 260
mg/m^2 or Taxol 175 mg/m^2 given every 2 weeks following dose-dense AC chemotherapy.
Bevacizumab will be administered at 10 mg/kg every 2 weeks throughout chemotherapy, and then
at 15 mg/kg every 3 weeks following chemotherapy.
Trial of Combination ABI-007, Carboplatin, and Gemcitabine for First Line Treatment of Advanced Urothelial Cancer [Recruiting]
This study will evaluate the safety and efficacy of the combination of ABI-007, carboplatin
and gemcitabine in the treatment of patients with advanced bladder cancer.
Study participants will have been diagnosed with advanced bladder cancer. Cisplatin based
chemotherapy in this setting has activity but is not curative. Furthermore, patients with
this disease have comorbidities that limit the use of cisplatin based therapy. Combination
paclitaxel, carboplatin and gemcitabine is active and well tolerated in this patient
Paclitaxel is formulated with ethanol and a Cremophor EL (polyoxyethylated castor oil) which
contribute to the side effects associated with paclitaxel. ABI-007 (brand name Abraxaneâ„¢) is
a form of paclitaxel that does not contain these additives and may deliver more drug to
tumor cells. ABI-007 is approved by the United States Food and Drug Administration (FDA) in
the treatment of metastatic (advanced) breast cancer based on superior anticancer effect,
and is being evaluated in other cancers in research studies.
Paclitaxel and ABI-007 in Treating Patients With Locally Advanced or Metastatic Solid Tumors [Active, not recruiting]
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and ABI-007, work in different ways
to stop tumor cells from dividing so they stop growing or die. Combining paclitaxel with
ABI-007 may kill more tumor cells.
PURPOSE: Randomized phase I trial to study the effectiveness of combining paclitaxel with
ABI-007 in treating patients who have locally advanced or metastatic solid tumors.
Page last updated: 2013-02-10