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
-

Chemotherapy and Lapatinib or Trastuzumab in Treating Women With HER2/Neu-Positive Metastatic Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2008-04-28
Last Posted Date
2022-08-02
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
652
Registration Number
NCT00667251
Locations
🇬🇧

Novartis Investigative Site, York, United Kingdom

Biomarkers in Women Receiving Chemotherapy & Celecoxib for Stage II or Stage III Breast Cancer Removable by Surgery

Phase 2
Terminated
Conditions
Breast Cancer
Interventions
Biological: filgrastim
Drug: capecitabine
Drug: celecoxib
Drug: cyclophosphamide
Drug: docetaxel
Drug: doxorubicin hydrochloride
Genetic: gene expression analysis
Genetic: polymorphism analysis
Genetic: protein expression analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: imaging biomarker analysis
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: pharmacogenomic studies
Procedure: dynamic contrast-enhanced magnetic resonance imaging
Procedure: needle biopsy
Procedure: neoadjuvant therapy
Procedure: radiomammography
Procedure: ultrasound imaging
First Posted Date
2008-04-23
Last Posted Date
2023-09-13
Lead Sponsor
University of Nebraska
Target Recruit Count
3
Registration Number
NCT00665457
Locations
🇺🇸

Unversity of Nebraska Medical Center, Omaha, Nebraska, United States

Cetuximab and Combination Chemotherapy in Patients With Stage III-IV Resectable Oropharynx Cancer

Phase 2
Completed
Conditions
Head and Neck Cancer
Interventions
First Posted Date
2008-04-23
Last Posted Date
2021-06-25
Lead Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Target Recruit Count
42
Registration Number
NCT00665392
Locations
🇫🇷

Hopital Bichat - Claude Bernard, Paris, France

🇫🇷

Hôpital Simone Veil, Montmorency, France

🇫🇷

Hôpital Privé St Joseph, Paris, France

and more 5 locations

Ph II Concurrent Chemo t/Docetaxel/Carboplatin/Radio Therapy-consolidation t/Locally Adv Inoperable Non-Small Cell Lung Cancer (NSCLC)

Phase 2
Terminated
Conditions
Lung Cancer
Interventions
Drug: Carboplatin
Drug: Docetaxel
Radiation: radiation therapy
First Posted Date
2008-04-22
Last Posted Date
2012-09-07
Lead Sponsor
Vanderbilt-Ingram Cancer Center
Target Recruit Count
63
Registration Number
NCT00664105
Locations
🇺🇸

Erlanger Health System, Chattanooga, Tennessee, United States

🇺🇸

Lehigh Valley Hospital - John & Dorothy Morgan Cancer Center, Allentown, Pennsylvania, United States

🇺🇸

The West Clinic, PC, Memphis, Tennessee, United States

and more 12 locations

A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer

Phase 1
Completed
Conditions
Advanced Cancer
Interventions
Drug: docetaxel
Drug: ANX-514
First Posted Date
2008-04-22
Last Posted Date
2009-05-28
Lead Sponsor
Mast Therapeutics, Inc.
Target Recruit Count
39
Registration Number
NCT00664170
Locations
🇺🇸

UCSD Moores Cancer Center, La Jolla, California, United States

🇪🇪

Tallinn Cancer Clinic, Tallinn, Estonia

🇺🇸

Signal Point Hematology/Oncology Inc., Middletown, Ohio, United States

and more 10 locations

A Study of Avastin (Bevacizumab) in Combination With Docetaxel and Cisplatin in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer

Phase 2
Completed
Conditions
Non-small Cell Lung Cancer
Interventions
First Posted Date
2008-04-18
Last Posted Date
2014-07-10
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
50
Registration Number
NCT00661778

Pemetrexed or Docetaxel With or Without Erlotinib in Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Phase 2
Completed
Conditions
Lung Cancer
Interventions
First Posted Date
2008-04-17
Last Posted Date
2015-10-12
Lead Sponsor
Case Comprehensive Cancer Center
Target Recruit Count
46
Registration Number
NCT00660816
Locations
🇺🇸

Columbia Presbyterian, New York City, New York, United States

🇺🇸

Lake/University Ireland Cancer Center, Cleveland, Ohio, United States

🇺🇸

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

and more 10 locations

A Feasibility Phase II Study in the Treatment of Resected Cholangiocarcinoma, Gallbladder, Pancreatic and Ampullary Cancers

Phase 2
Completed
Conditions
Gallbladder Cancer
Cholangiocarcinoma Cancer
Ampullary Cancer
Pancreatic Cancer
Interventions
First Posted Date
2008-04-17
Last Posted Date
2015-05-27
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
50
Registration Number
NCT00660699
Locations
🇺🇸

Washington University School of Medicine, St. Louis, Missouri, United States

Docetaxel, Bevacizumab and Androgen Deprivation Therapy After Definitive Local Therapy for Prostate Cancer

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2008-04-15
Last Posted Date
2017-05-25
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
42
Registration Number
NCT00658697
Locations
🇺🇸

University of Maryland - Greenebaum Cancer Center, Baltimore, Maryland, United States

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Adjuvant Treatment of Prostate Cancer With Docetaxel or Not After Radical Radiotherapy

Phase 3
Conditions
Prostate Cancer
Interventions
First Posted Date
2008-04-07
Last Posted Date
2021-03-25
Lead Sponsor
Scandinavian Prostate Cancer Group
Target Recruit Count
378
Registration Number
NCT00653848
Locations
🇳🇴

Jon R Iversen, Oslo, Norway

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