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
-

A Comparison of FLT to FDG PET/CT in the Early Assessment of Chemotherapy Response in Stage IB-IIIA Resectable NSCLC

Phase 2
Completed
Conditions
Stage IIB Non-Small Cell Lung Carcinoma
Stage IIA Non-Small Cell Lung Carcinoma
Stage IB Non-Small Cell Lung Carcinoma
Recurrent Non-Small Cell Lung Carcinoma
Stage IIIA Non-Small Cell Lung Cancer
Stage IV Non-Small Cell Lung Cancer
Interventions
Drug: Cisplatin
Procedure: CT
Drug: Docetaxel
Drug: FDG
Drug: FLT
Procedure: PET/CT
Procedure: Surgery
First Posted Date
2009-08-24
Last Posted Date
2017-03-17
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
26
Registration Number
NCT00963807
Locations
🇺🇸

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

🇺🇸

Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

Chemotherapy or Letrozole Before Surgery in Treating Postmenopausal Women With Breast Cancer That Can Be Removed By Surgery

First Posted Date
2009-08-21
Last Posted Date
2013-08-12
Lead Sponsor
Imperial College London
Target Recruit Count
756
Registration Number
NCT00963729
Locations
🇬🇧

St. Mary's Hospital, London, England, United Kingdom

🇰🇷

Asan Medical Center - University of Ulsan College of Medicine, Seoul, Korea, Republic of

🇬🇧

West Middlesex University Hospital, Isleworth, England, United Kingdom

and more 2 locations

A Translational Trial on Molecular Markers and Functional Imaging to Predict Response of Preoperative Treatment of Breast Cancer Early

Phase 2
Conditions
Breast Cancer
Interventions
First Posted Date
2009-08-12
Last Posted Date
2016-09-08
Lead Sponsor
Thomas Hatschek
Target Recruit Count
151
Registration Number
NCT00957125
Locations
🇸🇪

Lund University Hospital, Lund, Sweden

🇸🇪

Sahlgrenska University Hospital, Göteborg, Sweden

🇸🇪

Malmö General University Hospital, Malmö, Sweden

and more 3 locations

Carboplatin and Docetaxel Followed by Epstein-Barr Virus Cytotoxic T Lymphocytes

Phase 2
Completed
Conditions
Nasopharyngeal Carcinoma
Interventions
Drug: Docetaxel
Drug: Carboplatin
Drug: Dexamethasone
Biological: EBV-specific cytotoxic T lymphocytes
Biological: G-CSF or Peg-GCSF
First Posted Date
2009-08-06
Last Posted Date
2017-08-18
Lead Sponsor
Baylor College of Medicine
Target Recruit Count
20
Registration Number
NCT00953420
Locations
🇺🇸

Texas Children's Hospital, Houston, Texas, United States

🇺🇸

Houston Methodist Hospital, Houston, Texas, United States

🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

A Study to Compare Subcutaneous (SC) Versus Intravenous (IV) Administration of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer

First Posted Date
2009-07-31
Last Posted Date
2018-01-23
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
596
Registration Number
NCT00950300
Locations
🇦🇷

Centro Medico San Roque; Oncology Dept, Tucuman, Argentina

🇭🇺

Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika, Szeged, Hungary

🇲🇽

Hospital Privado San Jose; Oncologia, Obregon, Mexico

and more 103 locations

Docetaxel,Carboplatin,Trastuzumab and Bevacizumab for Breast Cancer and Bone Marrow Micrometastases

Early Phase 1
Completed
Conditions
Breast Cancer
Interventions
Biological: bevacizumab
Biological: trastuzumab
Drug: carboplatin
Drug: docetaxel
Other: laboratory biomarker analysis
First Posted Date
2009-07-30
Last Posted Date
2020-07-27
Lead Sponsor
Case Comprehensive Cancer Center
Target Recruit Count
20
Registration Number
NCT00949247
Locations
🇺🇸

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

🇺🇸

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

🇺🇸

University Hospitals Monarch, Mayfield Heights, Ohio, United States

and more 2 locations

CP-868,596 And CP-868,596 Plus AG-013736 In Combination With Docetaxel In Advanced Solid Tumors

Phase 1
Completed
Conditions
Advanced Solid Tumors
Interventions
Drug: CP-868,596
Drug: Docetaxel
Drug: AG-013736
First Posted Date
2009-07-30
Last Posted Date
2012-01-19
Lead Sponsor
Arog Pharmaceuticals, Inc.
Target Recruit Count
50
Registration Number
NCT00949624
Locations
🇦🇺

Pfizer Investigational Site, East Melbourne, Victoria, Australia

A Phase 2 Trial of Bevacizumab, Lenalidomide, Docetaxel, and Prednisone (ART-P) for Treatment of Metastatic Castrate-Resistant Prostate Cancer

Phase 2
Completed
Conditions
Metastatic Prostate Cancer
Interventions
First Posted Date
2009-07-21
Last Posted Date
2018-10-11
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
63
Registration Number
NCT00942578
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Exemestane or Docetaxel-Cytoxan in Low Recurrence Score Cancers

Phase 2
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2009-07-17
Last Posted Date
2017-04-10
Lead Sponsor
Emory University
Target Recruit Count
31
Registration Number
NCT00941330
Locations
🇺🇸

Emory University Hospital Midtown, Atlanta, Georgia, United States

🇺🇸

Emory University Winship Cancer Institute, Atlanta, Georgia, United States

🇺🇸

Grady Memorial Hospital, Atlanta, Georgia, United States

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