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Taxotere (Docetaxel) - Summary

 
 



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].

 

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.


See all Taxotere indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Taxotere (Docetaxel)

Docetaxel or pemetrexed with cisplatin achieve comparable outcomes in non-squamous lung cancer
Source: Lung Cancer News From Medical News Today [2014.09.29]
The first direct comparison of treating non-squamous lung cancer with either pemetrexed or docetaxel in addition to cisplatin has shown that the two combinations achieve similar progression-free...

Perjeta® (pertuzumab) first treatment for advanced breast cancer to extend survival by 15.7 months more than standard of care
Source: Breast Cancer News From Medical News Today [2014.09.29]
Perjeta, in combination with Herceptin® (trastuzumab) and chemotherapy (docetaxel), can extend survival in women with previously untreated, advanced HER2-positive breast cancer to over four and...

more news >>

Published Studies Related to Taxotere (Docetaxel)

Randomized phase II trial of docetaxel plus prednisone in combination with placebo or AT-101, an oral small molecule Bcl-2 family antagonist, as first-line therapy for metastatic castration-resistant prostate cancer. [2012]
AT-101 (A) or placebo in chemonaive mCRPC... CONCLUSIONS: AT-101 was tolerable but did not extend OS when combined with DP in

Randomized phase II trial of docetaxel plus prednisone in combination with placebo or AT-101, an oral small molecule Bcl-2 family antagonist, as first-line therapy for metastatic castration-resistant prostate cancer. [2011.11.29]
BACKGROUND: AT-101 (A), a small molecule oral inhibitor of the Bcl-2 family, has activity alone and in combination with docetaxel (Taxotere) and prednisone (DP) in metastatic castration-resistant prostate cancer (mCRPC). A randomized, double-blind, placebo-controlled phase II trial compared DP combined with either AT-101 (A) or placebo in chemonaive mCRPC... CONCLUSIONS: AT-101 was tolerable but did not extend OS when combined with DP in mCRPC; a potential benefit was observed in high-risk patients.

Epidermal growth factor receptor mutations are associated with docetaxel sensitivity in lung cancer. [2011.10]
INTRODUCTION: A recent large randomized controlled trial revealed that patients with lung cancer with epidermal growth factor receptor (EGFR) mutations had better prognoses when treated with the EGFR-tyrosine kinase inhibitor, gefitinib, than with cytotoxic chemotherapeutic agents. Lung cancer with EGFR mutations is highly sensitive to EGFR-tyrosine kinase inhibitors. The previous trial implied that EGFR mutations might be predictive of the response to cytotoxic chemotherapy... CONCLUSION: The histoculture drug response assay indicated that lung cancers with EGFR mutations were less sensitive to DOC than EGFR wild-type tumors.

Farnesyl transferase expression determines clinical response to the docetaxel-lonafarnib combination in patients with advanced malignancies. [2011.09.01]
BACKGROUND: Lonafarnib (LNF) is a protein farnesyl transferase (FTase) inhibitor that has shown synergistic activity with taxanes in preclinical models and early stage clinical trials. Preclinical findings suggested tubulin acetylation and FTase expression levels may be important determinants of drug sensitivity that would help identify patient populations more likely to benefit from this regimen. This pilot study evaluated the biological effects of LNF and docetaxel (DTX) combination therapy in refractory solid tumors by comparing pretreatment and post-treatment tumor biopsies... CONCLUSIONS: Despite the small number of patients, these findings support our preclinical mechanistic studies and warrant further clinical investigations using FTase-beta mRNA expression as a potential predictive biomarker to select for an enriched patient population to study the effects of taxane and FTase inhibitor combination therapies. Cancer 2011 (c) 2011 American Cancer Society.

Preliminary study of the specific endothelin a receptor antagonist zibotentan in combination with docetaxel in patients with metastatic castration-resistant prostate cancer. [2011.09]
BACKGROUND: This two-part study assessed the safety and tolerability of combined treatment with zibotentan (ZD4054), a specific endothelin A receptor antagonist, plus docetaxel in patients with metastatic castration-resistant prostate cancer... CONCLUSIONS: The tolerability of zibotentan plus docetaxel was consistent with the known profiles of each drug. Sufficient preliminary activity was seen with this combination to merit continued development. Copyright (c) 2011 Wiley-Liss, Inc.

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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 GleevecŪ (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.

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 >>


PATIENT REVIEWS / RATINGS / COMMENTS

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

  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.

See all Taxotere reviews / ratings >>

Page last updated: 2014-09-29

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