Paclitaxel Injection, USP 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 to 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.) Patients who experience severe hypersensitivity reactions to paclitaxel should not be rechallenged with the drug.
Paclitaxel Injection, USP therapy should not be given to patients with solid tumors who have baseline neutrophil counts of less than 1500 cells/mm3 and should not be given to patients with AIDS-related Kaposi's sarcoma if the baseline neutrophil count is less than 1000 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 Paclitaxel Injection, USP.
Paclitaxel Injection, USP 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.
Paclitaxel Injection, USP is indicated as first-line and subsequent therapy for the treatment of advanced carcinoma of the ovary. As first-line therapy, Paclitaxel Injection, USP is indicated in combination with cisplatin.
Paclitaxel Injection, USP is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor-negative tumors. (See
CLINICAL STUDIES: Breast Carcinoma.)
Paclitaxel Injection, USP 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.
Paclitaxel Injection, USP, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy.
Paclitaxel Injection, USP is indicated for the second-line treatment of AIDS-related Kaposi's sarcoma.
Published Studies Related to 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 Paclitaxel
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.
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.
Open-label Phase 1b Study of ARQ 092 in Combination With Carboplatin Plus Paclitaxel [Recruiting]
An Open-label Phase 1b Study of ARQ 092 in Combination with Carboplatin Plus Paclitaxel in
Subjects with Selected Solid Tumors
A Randomized Study of Intraperitoneal tgDCC-E1 and Intravenous Paclitaxel in Women With Platinum-Resistant Ovarian Cancer [Withdrawn]
Multi-Phase study (I/II) that did not progress to Phase II of clinical trial, terminated
early due to low accrual, separate ClinicalTrials. gov Registration NCT00102622 for Phase I
- Enrollment of up to 24 subjects in 8 cohorts of three subjects to one of three
combinations of intraperitoneal (IP) tgDCC-E1A + intravenous (IV) paclitaxel by the
continuous reassessment method (CRM) will be sufficient to establish the MTD
- The single agent paclitaxel cohort will consist of 24 subjects
- Enrollment of up to 20 subjects to one of three combinations of IP tgDCC-E1A + IV
paclitaxel decided by Phase I.
- The single-agent paclitaxel cohort will consist of 20 subjects.
Reports of Suspected Paclitaxel Side Effects
Febrile Neutropenia (123),
Hypertension (94), more >>
Page last updated: 2014-11-30