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
-

Neo-adjuvant Treatment in Non-Small Cell Lung Cancer (NSCLC)

Phase 2
Completed
Conditions
Lung Cancer
Interventions
Drug: cetuximab
Drug: cisplatin
Drug: docetaxel
Radiation: Radiotherapy
Procedure: Surgery
First Posted Date
2010-01-29
Last Posted Date
2022-03-11
Lead Sponsor
Swiss Group for Clinical Cancer Research
Target Recruit Count
69
Registration Number
NCT01059188
Locations
🇨🇭

Regionalspital, Thun, Switzerland

🇨🇭

UniversitaetsSpital Zuerich, Zurich, Switzerland

🇨🇭

Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland

and more 12 locations

Anthracycline-free Taxane Based Chemotherapy in Patients With HER2/Neu Negative Early Breast Cancer

Phase 3
Completed
Conditions
Her2 Non-overexpressing
Primary Breast Cancer
Interventions
First Posted Date
2010-01-14
Last Posted Date
2019-08-14
Lead Sponsor
West German Study Group
Target Recruit Count
3198
Registration Number
NCT01049425
Locations
🇩🇪

Bethesda Krankenhaus, Moenchengladbach, Germany

Lapatinib in Combination With Docetaxel in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer

Phase 1
Completed
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2010-01-08
Last Posted Date
2012-09-25
Lead Sponsor
Centre Georges Francois Leclerc
Target Recruit Count
17
Registration Number
NCT01044485
Locations
🇫🇷

Centre Georges François Leclerc, Dijon, Bourgogne, France

Tax First-line Chemotherapy With Different Doses and Then Maintenance Therapy

Phase 3
Completed
Conditions
Lung Neoplasms
Interventions
Drug: Docetaxel
Other: Best supportive care (BSC)
Drug: Cisplatin
First Posted Date
2009-12-24
Last Posted Date
2014-02-28
Lead Sponsor
Sanofi
Target Recruit Count
375
Registration Number
NCT01038661
Locations
🇨🇳

Sanofi-Aventis Administrative Office, Shanghai, China

A Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2009-12-24
Last Posted Date
2013-09-18
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
101
Registration Number
NCT01038804
Locations
🇺🇸

Gabrail Cancer Center, Canton, Ohio, United States

🇧🇪

Sint-Augustinus GZA Ziekenhuizen, Wilrijk, Belgium

🇺🇸

Bay Area Cancer Research Group, Pleasant Hill, California, United States

and more 27 locations

Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma

Phase 3
Terminated
Conditions
Stage IIIB Uterine Sarcoma
Stage IIIC Uterine Sarcoma
Stage IVA Uterine Sarcoma
Recurrent Uterine Corpus Sarcoma
Uterine Corpus Leiomyosarcoma
Stage IIIA Uterine Sarcoma
Stage IVB Uterine Sarcoma
Interventions
Biological: Bevacizumab
Drug: Docetaxel
Drug: Gemcitabine Hydrochloride
Biological: Filgrastim
Biological: Pegfilgrastim
Other: Placebo
First Posted Date
2009-11-13
Last Posted Date
2020-09-02
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
107
Registration Number
NCT01012297
Locations
🇺🇸

USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

🇺🇸

UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

🇺🇸

Los Angeles County-USC Medical Center, Los Angeles, California, United States

and more 197 locations

Docetaxel With a Phytochemical in Treating Patients With Hormone Independent Metastatic Prostate Cancer

Phase 2
Completed
Conditions
Metastatic Prostate Cancer
First Posted Date
2009-11-11
Last Posted Date
2013-04-10
Lead Sponsor
Centre Jean Perrin
Target Recruit Count
30
Registration Number
NCT01012141
Locations
🇫🇷

Centre Jean Perrin, Clermont-Ferrand, France

🇫🇷

Institut Jean Godinot, Reims, France

A Study of YM155 Plus Docetaxel in Subjects With Stage III (Unresectable) or Stage IV Melanoma

Phase 2
Completed
Conditions
Melanoma
Interventions
First Posted Date
2009-11-09
Last Posted Date
2015-09-04
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
64
Registration Number
NCT01009775
Locations
🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

🇺🇸

University of Colorado, Aurora, Colorado, United States

🇺🇸

University of South Alabama, Mobile, Alabama, United States

and more 8 locations

Low Dose Weekly Docetaxel Versus Pemetrexed in Previously Treated Advanced Non-Small-Cell Lung Cancer

Not Applicable
Completed
Conditions
Non Small Cell Lung Cancer
Interventions
First Posted Date
2009-10-30
Last Posted Date
2009-10-30
Lead Sponsor
Chang Gung Memorial Hospital
Target Recruit Count
179
Registration Number
NCT01004601
Locations
🇨🇳

Chang Gung Memorial Hospital, Taipei, Taiwan

Study of Bevacizumab and Erlotinib for Patients With Hormone Refractory Prostate Cancer

Phase 1
Terminated
Conditions
Prostate Cancer
Interventions
First Posted Date
2009-10-16
Last Posted Date
2019-03-27
Lead Sponsor
Columbia University
Target Recruit Count
4
Registration Number
NCT00996502
Locations
🇺🇸

Columbia University Medical Center, New York, New York, United States

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