DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Taxotere (Docetaxel) - Summary



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].



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.

See all Taxotere indications & dosage >>


Media Articles Related to Taxotere (Docetaxel)

Study finds drug improves survival for patients with non-small cell lung cancer
Source: Clinical Trials / Drug Trials News From Medical News Today [2015.09.28]
A new phase 3 trial finds that overall survival is longer for patient with non-small cell lung cancer treated with the drug nivolumab compared with chemotherapy drug docetaxel.

more news >>

Published Studies Related to Taxotere (Docetaxel)

Randomized phase III trial of gemcitabine plus docetaxel plus bevacizumab or placebo as first-line treatment for metastatic uterine leiomyosarcoma: an NRG Oncology/Gynecologic Oncology Group study. [2015]
progression-free survival (PFS) in uLMS... CONCLUSION: The addition of bevacizumab to gemcitabine-docetaxel for first-line

Safety profile of Pertuzumab with Trastuzumab and Docetaxel in patients from Asia with human epidermal growth factor receptor 2-positive metastatic breast cancer: results from the phase III trial CLEOPATRA. [2014]
metastatic breast cancer... CONCLUSION: Despite a higher proportion of docetaxel dose reductions in patients

DOC-MEK: a double-blind randomized phase II trial of docetaxel with or without selumetinib in wild-type BRAF advanced melanoma. [2014]
wild-type BRAF advanced melanoma... CONCLUSIONS: The combination of docetaxel with selumetinib showed no significant

[Efficacy and safety of rh-endostatin combined with docetaxel in second-line or intolerant toxicity for first-line treatment in patients with advanced non-small cell lung cancer]. [Article in Chinese] [2013]
chemotherapy... CONCLUSIONS: Endostar may prolong TTP in patients with advanced NSCLC benefited

Docetaxel and atrasentan versus docetaxel and placebo for men with advanced castration-resistant prostate cancer (SWOG S0421): a randomised phase 3 trial. [2013]
bone metastases... INTERPRETATION: Atrasentan, when added to docetaxel, does not improve overall

more studies >>

Clinical Trials Related to Taxotere (Docetaxel)

Pharmacokinetic Study of CKD-810 and Taxotere to Treat Patient With Advanced Solid Cancer [Completed]
The purpose of this study is to evaluate safety and the pharmacokinetic characteristics of docetaxel between two docetaxel products in patients with advanced solid cancer.

Taxotere and Adriamycin/Cytoxan (AC) Validation in Breast Cancer Patients [Recruiting]
The purpose of this study is to learn if the biomarker information obtained (learned or received) from the earlier studies can tell us whether or not Taxotere and/or Adriamycin/Cytoxan can cause tumors to become smaller.

Biomarker Study for Sunitinib and Docetaxel in Prostate Cancer [Recruiting]
Docetaxel and sunitinib will be compared to docetaxel for their effect on CEC/CEP spikes induced by docetaxel in HRPC patients

Extension Neoadjuvant Taxotere: Study of the Effects of Taxotere in Patients With Breast Cancer [Terminated]
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.

Study to Evaluate Combination Treatment of MGCD0103 and Docetaxel (TaxotereŽ) for Subjects With Advanced Cancer Tumors [Terminated]
The purpose of this study is to test the combination of an experimental drug known as MGCD0103 given along with an FDA-approved drug called docetaxel. This is a Phase 1 study that will look at different doses of MGCD0103 given along with docetaxel in order to better understand the effects (positive and negative) of this combination on the subject's body and disease. The study would like to find the following information:

- How long MGCD0103 and docetaxel stay in the subject's body;

- What effects, good and/or bad, MGCD0103 and docetaxel have on the subject and on

his/her cancer; and

- If the genetic and chemical make-up of the subject's blood cells and tumor cells play a

role in how you respond or do not respond to MGCD0103 and docetaxel.

more trials >>

Reports of Suspected Taxotere (Docetaxel) Side Effects

Interstitial Lung Disease (58)Dyspnoea (56)Neutropenia (53)Pyrexia (50)Diarrhoea (49)Nausea (37)Febrile Neutropenia (36)Dehydration (33)Death (31)Hypotension (30)more >>


Based 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

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.

See all Taxotere reviews / ratings >>

Page last updated: 2015-09-28

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2015