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)
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 Onxol (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.
Gemcitabine + Nab-paclitaxel With LDE-225 (Hedgehog Inhibitor) as Neoadjuvant Therapy for Pancreatic Adenocarcinoma [Active, not recruiting]
This is an open-label phase 1/2 study that will combine the chemotherapy agents gemcitabine
and nab-paclitaxel with an oral hedgehog inhibitor LDE225. The objective is to assess
tolerability and the resection rate of patients with borderline resectable pancreatic
adenocarcinoma who use this treatment.
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.
A Phase I Trial of the Combination of AZD2014 and Weekly Paclitaxel. [Recruiting]
This is a Phase I study to evaluate the safety and toxicity profile of AZD2014, a novel
anticancer agent, in combination with paclitaxel.
AZD2014 will be given orally, twice daily at a starting dose of 25 mg per day for 3 days on,
4 days off with a weekly infusion of 80 mg of paclitaxel for 6 weeks followed by a treatment
break of one week, therefore each cycle will be 7 weeks long. Cohorts of three patients will
be treated at this dose of AZD2014 and then at 50mg and 75 mg providing is it safe to do so.
Once we have determined the maximum tolerated dose (MTD) using the 3 days on, 4 days off
schedule of AZD2014, patients will be given AZD2014 2 days on, 5 days with their paclitaxel
infusion. Patients will be enrolled in cohorts of three to evaluate three escalating doses
of AZD2014 to determine the MTD for the 2 days on, 5 days off schedule.
On completion of the dose escalation phase of the study patients with ovarian cancer and
squamous cell lung cancer will be treated at the MTD established for each dosing schedule. A
minimum of 10 ovarian cancer patients and 15 squamous cell lung patients will be enrolled to
the 3 days on, 4 days off schedule. Whilst a minimum of 10 squamous cell cancer patients
will be enrolled to the 2 days on, 5 days off schedule to further assess the tolerability of
the combination of AZD2014 and paclitaxel.
BKM120 + Carboplatin + Paclitaxel for Patients With Advanced Solid Tumors [Recruiting]
The purpose of this study is to find out the good and bad effects that occur when BKM120 is
added to standard chemotherapy with carboplatin and paclitaxel.
Page last updated: 2014-11-30