WARNING
The incidence of treatment-related mortality associated with TAXOTERE therapy is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive TAXOTERE as a single agent at a dose of 100 mg/m2 [see Warnings and Precautions].
TAXOTERE should generally not be given to patients with bilirubin > upper limit of normal (ULN), or to patients with SGOT and/or SGPT >1.5 × ULN concomitant with alkaline phosphatase >2.5 × ULN. Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of grade 4 neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Patients with isolated elevations of transaminase >1.5 × ULN also had a higher rate of febrile neutropenia grade 4 but did not have an increased incidence of toxic death. Bilirubin, SGOT or SGPT, and alkaline phosphatase values should be obtained prior to each cycle of TAXOTERE therapy and reviewed by the treating physician.
TAXOTERE therapy should not be given to patients with neutrophil counts of <1500 cells/mm3. In order to monitor the occurrence of neutropenia, which may be severe and result in infection, frequent blood cell counts should be performed on all patients receiving TAXOTERE.
Severe hypersensitivity reactions characterized by generalized rash/erythema, hypotension and/or bronchospasm, or very rarely fatal anaphylaxis, have been reported in patients who received the recommended 3-day dexamethasone premedication. Hypersensitivity reactions require immediate discontinuation of the TAXOTERE infusion and administration of appropriate therapy [see Warnings and Precautions]. TAXOTERE must not be given to patients who have a history of severe hypersensitivity reactions to TAXOTERE or to other drugs formulated with polysorbate 80 [see Contraindications (4) ].
Severe fluid retention occurred in 6.5% (6/92) of patients despite use of a 3-day dexamethasone premedication regimen. It was characterized by one or more of the following events: poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites) [see Warnings and Precautions].
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TAXOTERE SUMMARY
Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-
tert
-butyl ester, 13-ester with 5(beta)-20-epoxy-1,2(alpha),4,7(beta),10(beta),13(alpha)-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate, trihydrate.
TAXOTERE is indicated for the following:
Breast Cancer: TAXOTERE is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.
Non-Small Cell Lung Cancer: TAXOTERE as a single agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy.
TAXOTERE in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition.
Prostate Cancer: TAXOTERE in combination with prednisone is indicated for the treatment of patients with androgen independent (hormone refractory) metastatic prostate cancer.
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NEWS HIGHLIGHTSMedia Articles Related to Taxotere (Docetaxel)
NeoPharm Presents The Phase I Data For Patients With Metastatic Solid Tumors
Source: Cancer / Oncology News From Medical News Today [2009.11.19]
NeoPharm, Inc. (Other OTC: NEOL.PK) announced the results of a Phase I clinical trial of Liposome Encapsulated Docetaxel (LE-DT) an active component of Taxotere® at a joint International Conference of the American Association for Cancer Research (AACR), the National Cancer Institute (NCI) and the European Organization for Research and Treatment of Cancer (EORTC) being held in Boston, MA.
Published Studies Related to Taxotere (Docetaxel)
Neoadjuvant chemotherapy with carboplatin and docetaxel in advanced ovarian cancer--a prospective multicenter phase II trial (PRIMOVAR). [2009.09]
Early response criteria and surgical outcome were evaluated in patients with advanced epithelial ovarian cancer treated with neoadjuvant chemotherapy. Patients with FIGO stage IIIC or IV ovarian cancer and an ascites volume of >or=500 ml were randomly assigned to receive preoperatively 3 (A1) or 2 (A2) of 6 cycles of carboplatin and docetaxel intravenously...
A randomized, placebo-controlled, double-blind phase 2 study of docetaxel compared to docetaxel plus zosuquidar (LY335979) in women with metastatic or locally recurrent breast cancer who have received one prior chemotherapy regimen. [2009.09]
PURPOSE: To determine if concomitant administration of docetaxel plus zosuquidar.3HC1 can prolong progression-free survival in patients with metastatic breast cancer... CONCLUSION: The combination of zosuquidar.3HCl plus docetaxel is safe. The analysis of efficacy data is complex, but it can be concluded that there is no difference in progression-free survival, overall survival, or response rate in the study as a whole.
Significantly longer progression-free survival with nab-paclitaxel compared with docetaxel as first-line therapy for metastatic breast cancer. [2009.08.01]
PURPOSE: In patients with metastatic breast cancer (MBC), nab-paclitaxel produced significantly higher antitumor activity compared with patients who received solvent-based paclitaxel. This phase II study examined the antitumor activity and safety of weekly and every 3 week (q3w) nab-paclitaxel compared with docetaxel as first-line treatment in patients with MBC... CONCLUSION: This randomized study in first-line MBC demonstrated superior efficacy and safety of weekly nab-paclitaxel compared with docetaxel, with a statistically and clinically significant prolongation of PFS (> 5 months) in patients receiving nab-paclitaxel 150 mg/m(2) weekly compared with docetaxel 100 mg/m(2) q3w.
Docetaxel plus oblimersen sodium (Bcl-2 antisense oligonucleotide): an EORTC multicenter, randomized phase II study in patients with castration-resistant prostate cancer. [2009.07]
BACKGROUND: This randomized, phase II study assessed the activity of oblimersen sodium, a Bcl-2 antisense oligonucleotide, administered before docetaxel (Taxotere) to patients with castration-resistant prostate cancer... CONCLUSIONS: The primary end points of the study were not met: a rate of confirmed PSA response >30% and a major toxic event rate <45% were not observed with docetaxel-oblimersen.
Global Lung Oncology Branch trial 3 (GLOB3): final results of a randomised multinational phase III study alternating oral and i.v. vinorelbine plus cisplatin versus docetaxel plus cisplatin as first-line treatment of advanced non-small-cell lung cancer. [2009.07]
BACKGROUND: The study compared the efficacy of a first-line treatment with day 1 i.v. vinorelbine (NVBiv) and day 8 oral vinorelbine (NVBo) versus docetaxel (DCT) in a cisplatin-based combination in advanced non-small-cell lung cancer, in terms of time to treatment failure (TTF), overall response, progression-free survival (PFS), overall survival (OS), tolerance and quality of life (QoL)... CONCLUSIONS: Both arms provided similar efficacy in terms of response, time-related parameters and QoL, with an acceptable tolerance profile. In the current Global Lung Oncology Branch trial 3, NVBo was shown to be effective as a substitute for the i.v. formulation. This can relieve the burden of the i.v. injection on day 8 and can optimise the hospital's resources and improve patient convenience.
Clinical Trials Related to Taxotere (Docetaxel)
Extension Neoadjuvant Taxotere: Study of the Effects of Taxotere in Patients With Breast Cancer [Active, not recruiting]
We, the investigators at Baylor Breast Care Cancer, are doing this study to learn how well
Taxotere makes tumors become smaller. We are also doing this study to find out how well
Taxotere treats the type of breast cancer that some patients have. We are asking patients to
take part in this study because they have locally advanced breast cancer. Women with this
breast cancer will usually receive chemotherapy medicines to reduce or shrink the cancer
before surgery to take out the cancer. If patients choose to take part in this study, they
will receive Taxotere and the combination of cyclophosphamide and doxorubicin. These
medicines are part of the standard good medical care for this type of breast cancer. They are
approved for the treatment of this problem. To help us learn how the patients' cancer
responds to these medicines, we will take a small tissue sample (biopsy) of the patients'
breast cancer before beginning treatment, one day after the first dose of treatment, once
each week for the first three weeks of treatment, and when surgery is done as part of
treatment for their cancer. These samples will be collected also to look at the biology of
the patients' cancer. We will also use a new method called cDNA array technology, which lets
us look at thousands of genes (coding information inside the cancer cell) at once. By looking
at different genes in the breast cancer, we may learn important information about which
cancers will respond to a chemotherapy medicine. We hope to learn if there are different gene
patterns in patients whose tumors shrink or do not shrink with this chemotherapy medicine.
This information may help us, in the future, to choose the right medicines for women with
breast cancer so that they have the highest chance of their cancer shrinking with
chemotherapy medicine. We cannot and do not know if patients will benefit if they take part
in this study.
A Phase 2 Study in Patients With Advanced Non-Small Cell Lung Cancer Using New Agents With and Without Docetaxel. [Withdrawn]
ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-Small Cell Lung Cancer [Active, not recruiting]
This large phase III clinical study is studying the effect of vandetanib (ZACTIMA) in
treating non-small cell lung cancer (NSCLC). Vandetanib is a new type of agent that targets
the blood supply to a cancer tumour (through it's anti-VEGFR properties) and the tumour cells
themselves (through it's anti-EGFR actions). This study will look at the effects of
vandetanib in lung cancer patients who have had their cancer re-appear after treatment with
standard chemotherapy.
This clinical study will test if the vandetanib anti-VEGF and anti-EGFR characteristics can
deliver longer improved progression free survival and improved overall survival than
docetaxel (Taxotere) alone.
All patients participating this clinical study will receive treatment with docetaxel, a
commonly used treatment for recurrent non-small cell lung cancer.
In addition, some patients will also receive vandetanib (ZACTIMA), an anti-EGFR / anti-VEGF
agent.
Recent clinical research shows that vascular endothelial growth factor receptor (VEGFR)
inhibition, when used with standard chemotherapy, can lead to increased survival in advanced
non-small cell lung cancer (NSCLC) patients.
Other research shows that epidermal growth factor receptor (EGFR) inhibitors, like erlotinib
(Tarceva) can also increase overall non-small cell lung cancer survival by killing tumour
cells and stopping them from dividing.
Iressa and Taxotere Study in Patients With Metastatic Urothelial Cancer [Active, not recruiting]
Primary Objective:
1. To compare the proportion of patients free from progression 9 months from the start of
consolidation therapy with the combination of docetaxel and ZD1839 versus docetaxel alone.
For the purposes of this protocol, "consolidation" therapy refers to treatment given at the
time of maximal benefit from conventional front-line multi-agent chemotherapy.
Secondary Objective:
1. To compare time to progression (TTP), overall survival (OS) and cause-specific survival
(CSS) in the two arms. For completeness, these will be reported both from the initiation of
consolidation chemotherapy, and from the completion of induction chemotherapy.
Phase II Trial of Gleevec and Taxotere as a Combined Regimen for Advanced Gastric Adenocarcinoma [Terminated]
The purpose of this trial is to test the combination of Gleevec® (also known as imatinib
mesylate) and Taxotere (also known as docetaxel) in patients with incurable stomach cancer.
This study is being performed to see if the combination of Gleevec and Taxotere is an
effective treatment for incurable stomach cancer with minimal side effects.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Taxotere has an overall score of 8. The effectiveness score is 10 and the side effect score is 4. The scores are on ten point scale: 10 - best, 1 - worst.
| | Taxotere review by 48 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Highly Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Cancer |
| Dosage & duration: | | not sure standard for breast cancer (dosage frequency: 3 weeks) for the period of 6 cycles |
| Other conditions: | | netropenia |
| Other drugs taken: | | tamoxien | | |
Reported Results |
| Benefits: | | Longer life expectancy but wish I had know that my ovaries could be turned off before I started the drug then switched on again afterwards. As it is I went into a early menopuse with very, very, severe side effects.Please get your Doctor to talk about ALL the possible side effects of menopause, including sexual. |
| Side effects: | | netropenia, stort of breath , muscle weakness, nausea, hair loss, menopuse, unable to find any peace of mind. Would reccomend eating bucket fulls of fruit. |
| Comments: | | 1 injection every 3 weeks. Then a reduction in the dose by 25 percente after the 4 th week due to netropenia. |
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Page last updated: 2009-11-19
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