MedPath

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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Taxotere (Docetaxel) New Indication: Squamous Cell Carcinoma of the Head and Neck (SCCHN) Treatment Registration Trial

Phase 3
Completed
Conditions
Head and Neck Neoplasms
Interventions
First Posted Date
2009-10-15
Last Posted Date
2018-03-02
Lead Sponsor
Sanofi
Target Recruit Count
240
Registration Number
NCT00995293
Locations
🇨🇳

Sanofi Administrative Office, Shanghai, China

Doxorubicin Hydrochloride, Cyclophosphamide, Docetaxel, and S-1 Before Surgery in Treating Women With Stage II or Stage III Breast Cancer

Phase 2
Conditions
Breast Cancer
First Posted Date
2009-10-14
Last Posted Date
2010-10-29
Lead Sponsor
Yonsei University
Target Recruit Count
49
Registration Number
NCT00994968
Locations
🇰🇷

Yonsei Cancer Center at Yonsei University Medical Center, Seoul, Korea, Republic of

Study of Blood and Tissue Samples in Predicting Response to Second-Line Therapy Using Erlotinib Hydrochloride or Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer

Phase 3
Conditions
Lung Cancer
First Posted Date
2009-10-05
Last Posted Date
2013-08-12
Lead Sponsor
Istituto Scientifico H. San Raffaele
Target Recruit Count
275
Registration Number
NCT00989690
Locations
🇮🇹

Istituto Scientifico H. San Raffaele, Milan, Italy

Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer

Phase 3
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2009-10-02
Last Posted Date
2018-04-04
Lead Sponsor
Celgene
Target Recruit Count
1059
Registration Number
NCT00988208
Locations
🇺🇸

Cookeville Regional Medical Center, Cookeville, Tennessee, United States

🇺🇸

Veterans Education and Research Association of Northern New England, Inc., White River Junction, Vermont, United States

🇦🇹

Medizinische Universitat Wien, Vienna, Austria

and more 206 locations

Docetaxel Versus Docetaxel Plus Cisplatin Versus Docetaxel Plus S-1 as Second-line Chemotherapy in Metastatic Gastric Cancer

Phase 2
Conditions
Gastric Cancer
Interventions
First Posted Date
2009-09-21
Last Posted Date
2009-09-21
Lead Sponsor
National Cancer Center, Korea
Target Recruit Count
144
Registration Number
NCT00980603
Locations
🇰🇷

Seoul National University Bundang Hospital, Seongnam, Korea, Republic of

🇰🇷

Research Institute and Hospital, National Cancer Center Korea, Goyang, Korea, Republic of

🇰🇷

Chungbuk National University Hospital, Chonju, Korea, Republic of

and more 1 locations

Biweekly Avastin and Docetaxel as the First Line Treatment for Patients With Metastatic Breast Cancer

Phase 2
Terminated
Conditions
Neoplasms
Interventions
First Posted Date
2009-09-18
Last Posted Date
2019-03-28
Lead Sponsor
Tampere University Hospital
Target Recruit Count
65
Registration Number
NCT00979641
Locations
🇫🇮

Tampere Unviersity Hospital, Tampere, Finland

Symptom Control With or Without Docetaxel in Treating Patients With Relapsed Esophageal Cancer or Stomach Cancer

Phase 3
Completed
Conditions
Adenocarcinoma of the Gastroesophageal Junction
Esophageal Cancer
Gastric Cancer
Nausea and Vomiting
Pain
First Posted Date
2009-09-17
Last Posted Date
2013-08-07
Lead Sponsor
Cambridge University Hospitals NHS Foundation Trust
Target Recruit Count
320
Registration Number
NCT00978549
Locations
🇬🇧

Addenbrooke's Hospital, Cambridge, England, United Kingdom

🇬🇧

St. Luke's Cancer Centre at Royal Surrey County Hospital, Guildford, England, United Kingdom

🇬🇧

Medical Research Council Clinical Trials Unit, London, England, United Kingdom

and more 5 locations

A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Participants With HER2-Positive Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2009-09-15
Last Posted Date
2017-02-06
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
225
Registration Number
NCT00976989

Bevacizumab, Docetaxel, and Gemcitabine Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

Phase 2
Completed
Conditions
Lung Cancer
Interventions
First Posted Date
2009-09-02
Last Posted Date
2022-08-16
Lead Sponsor
Nathan Pennell, MD, PhD
Target Recruit Count
13
Registration Number
NCT00970684
Locations
🇺🇸

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

🇺🇸

Fairview Hospital, Moll Pavilion, Cleveland, Ohio, United States

🇺🇸

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

and more 1 locations

Cisplatin, Capecitabine, Gemcitabine and Epirubicin or Docetaxel for Patients With Stage III or IV Pancreatic Cancer

First Posted Date
2009-08-27
Last Posted Date
2012-02-01
Lead Sponsor
IRCCS San Raffaele
Target Recruit Count
105
Registration Number
NCT00966706
Locations
🇮🇹

San Raffaele Scientific Institute, Milan, Italy

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