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Docetaxel

Generic Name
Docetaxel
Brand Names
Taxotere, Docetaxel Accord, Docetaxel Kabi
Drug Type
Small Molecule
Chemical Formula
C43H53NO14
CAS Number
114977-28-5
Unique Ingredient Identifier
699121PHCA
Background

Docetaxel is a clinically well established anti-mitotic chemotherapy medication used for the treatment of different types of cancer, including breast, ovarian, and non-small cell lung cancer. Docetaxel is a complex diterpenoid molecule and a semisynthetic analogue of paclitaxel. Docetaxel reversibly binds to microtubulin with high affinity in a 1:1 stoichiometric ratio, allowing it to prevent cell division and promote to cell death. Compared to paclitaxel, docetaxel is two times more potent as an inhibitor of microtubule depolymerization. Docetaxel binds to microtubules but does not interact with dimeric tubulin.

The use of docetaxel may lead to udesired outcomes such as hepatic impairment, hematologic effects, enterocolitis and neutropenic colitis, hypersensitivity reactions, fluid retention, second primary malignancies, embryo-fetal toxicity, and tumor lysis syndrome. Docetaxel was approved by the FDA in 1996 and is available in solution for injection for intravenous or parenteral administration.

Indication

Docetaxel is indicated as a single agent for the treatment of locally advanced or metastatic breast cancer after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC. It is also indicated as a single agent for locally advanced or metastatic non-small cell lung cancer (NSCLC) after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC. For the treatment of metastatic castration-resistant prostate cancer, docetaxel is indicated with prednisone. Docetaxel is also indicated with cisplatin and fluorouracil for untreated, advanced gastric adenocarcinoma, including the gastroesophageal junction, and with cisplatin and fluorouracil for induction treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN).

Associated Conditions
Esophageal Cancer, Ewing's Sarcoma, Locally Advanced Breast Cancer (LABC), Metastatic Bladder Cancer, Metastatic Breast Cancer, Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC), Node Positive Breast Cancer, Ovarian Cancer Metastatic, Small Cell Lung Cancer (SCLC), Soft Tissue Sarcoma, Advanced untreated gastric adenocarcinoma, Locally advanced Squamous cell carcinoma of head and neck, Locally advanced untreated non small cell lung cancer, Metastatic untreated non small cell lung cancer, Refractory, locally advanced Non small cell lung cancer, Refractory, metastatic Non small cell lung cancer, Refractory, metastatic hormone-refractory Prostate cancer
Associated Therapies
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A Study of Xeloda (Capecitabine) in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer.

First Posted Date
2007-04-02
Last Posted Date
2016-09-29
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
158
Registration Number
NCT00454636

PARTNER: Panitumumab Added to Regimen for Treatment of Head aNd Neck Cancer Evaluation of Response

Phase 2
Completed
Conditions
Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck
Interventions
First Posted Date
2007-04-02
Last Posted Date
2018-10-17
Lead Sponsor
Amgen
Target Recruit Count
113
Registration Number
NCT00454779
Locations
🇪🇸

Research Site, Madrid, Spain

Study With Docetaxel, Carboplatin and Herceptin Versus Vinorelbine and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients

Phase 2
Terminated
Conditions
Breast Cancer
Interventions
First Posted Date
2007-03-29
Last Posted Date
2012-03-13
Lead Sponsor
Hellenic Oncology Research Group
Target Recruit Count
88
Registration Number
NCT00453635
Locations
🇬🇷

University General Hospital of Alexandroupolis, Dep of Medical Oncology, Alexandroupolis, Greece

🇬🇷

Air Forces Military Hospital of Athens, Athens, Greece

🇬🇷

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine, Athens, Greece

and more 7 locations

Docetaxel and Radiation Therapy in Treating Patients With Stage II, Stage III, or Stage IV Cervical Cancer

Phase 1
Withdrawn
Conditions
Cervical Cancer
First Posted Date
2007-03-28
Last Posted Date
2016-12-15
Lead Sponsor
University of Miami
Registration Number
NCT00452920
Locations
🇺🇸

University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, United States

Docetaxel and Carboplatin as First-line Chemotherapy in Early Stage as Well as Advanced or Metastatic Ovarian Cancer

Completed
Conditions
Ovarian Neoplasms
Interventions
First Posted Date
2007-03-28
Last Posted Date
2012-08-14
Lead Sponsor
Sanofi
Target Recruit Count
30
Registration Number
NCT00452985
Locations
🇧🇩

Sanofi-Aventis, Dhaka, Bangladesh

The ELDORADO (Eligard®, Docetaxel and Radiotherapy) Study

Phase 2
Conditions
Prostatic Neoplasms
Interventions
Drug: Docetaxel
Drug: Leuprolide Acetate (Eligard®)
Radiation: Intensity-Modulated Radiotherapy
First Posted Date
2007-03-27
Last Posted Date
2014-03-19
Lead Sponsor
Nova Scotia Cancer Centre
Target Recruit Count
86
Registration Number
NCT00452556
Locations
🇨🇦

Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada

Safety and Efficacy Study of GM-CSF, Thalidomide Plus Docetaxel in Prostate Cancer

Phase 2
Terminated
Conditions
Prostatic Neoplasms
Interventions
First Posted Date
2007-03-21
Last Posted Date
2016-03-17
Lead Sponsor
The Methodist Hospital Research Institute
Target Recruit Count
9
Registration Number
NCT00450008
Locations
🇺🇸

The Methodist Hospital Research Institute, Houston, Texas, United States

A Study of Picoplatin and Docetaxel in Subjects With Prostate Cancer

Phase 1
Conditions
Hormone Refractory Prostate Cancer
Interventions
First Posted Date
2007-03-19
Last Posted Date
2009-01-21
Lead Sponsor
Poniard Pharmaceuticals
Target Recruit Count
95
Registration Number
NCT00448734
Locations
🇷🇺

Medical Radiology Research Center under the Russian Academy of Medical Sciences, Obninsk, Kaluga Region, Russian Federation

🇷🇺

Leningrad Regional Oncology Center, St. Petersburg, Russian Federation

🇷🇺

St. Petersburg City Hospital #26, St. Petersburg, Russian Federation

and more 8 locations

Combination Chemotherapy in Treating Patients With Previously Untreated Stage II or Stage III Esophageal Cancer That Can Be Removed By Surgery

Phase 2
Completed
Conditions
Esophageal Cancer
Interventions
Drug: Docetaxel
Drug: Floxuridine
Drug: Leucovorin
Drug: Oxaliplatin
Genetic: Microarray analysis
Genetic: reverse transcriptase-polymerase chain reaction
Procedure: Conventional surgery
First Posted Date
2007-03-19
Last Posted Date
2017-02-07
Lead Sponsor
University of Miami
Target Recruit Count
29
Registration Number
NCT00448760
Locations
🇺🇸

University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida, United States

Combination Chemotherapy as First-Line Therapy in Treating Patients With Stage IV Gastric Cancer That Cannot Be Removed By Surgery

Phase 2
Terminated
Conditions
Gastric Cancer
Interventions
First Posted Date
2007-03-19
Last Posted Date
2017-02-07
Lead Sponsor
University of Miami
Target Recruit Count
25
Registration Number
NCT00448682
Locations
🇺🇸

University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida, United States

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