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
-

LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib

Phase 3
Completed
Conditions
Non-Small Cell Lung Cancer
Interventions
First Posted Date
2013-04-10
Last Posted Date
2023-11-30
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
231
Registration Number
NCT01828112
Locations
🇬🇧

Novartis Investigative Site, London, United Kingdom

Docetaxel With or Without FGFR Inhibitor AZD4547 in Treating Patients With Recurrent Non-Small Cell Lung Cancer

Phase 1
Completed
Conditions
Squamous Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Interventions
Drug: docetaxel
Drug: AZD4547
First Posted Date
2013-04-05
Last Posted Date
2023-06-29
Lead Sponsor
ECOG-ACRIN Cancer Research Group
Target Recruit Count
2
Registration Number
NCT01824901
Locations
🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

🇺🇸

Emory University, Atlanta, Georgia, United States

🇺🇸

Northwestern University, Chicago, Illinois, United States

and more 2 locations

Study of Safety & Efficacy of the Combination of LJM716 & BYL719 in Patients With Previously Treated Esophageal Squamous Cell Carcinoma (ESCC)

Phase 1
Completed
Conditions
Esophageal Squamous Cell Carcinoma
Interventions
First Posted Date
2013-04-02
Last Posted Date
2020-12-19
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
48
Registration Number
NCT01822613
Locations
🇬🇧

Novartis Investigative Site, Manchester, United Kingdom

🇺🇸

University of Chicago Medical Center Dept of Onc, Chicago, Illinois, United States

🇺🇸

Karmanos Cancer Institute Dept of Onc, Detroit, Michigan, United States

and more 1 locations

Endostar + GT in Pulmonary Metastases of Soft Tissue Sarcoma

Phase 2
Conditions
Soft Tissue Sarcoma
Interventions
First Posted Date
2013-03-15
Last Posted Date
2013-03-15
Lead Sponsor
Peng Yuan
Target Recruit Count
30
Registration Number
NCT01812018
Locations
🇨🇳

Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, China

Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer

Phase 2
Recruiting
Conditions
Stage III Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
Stage IV Laryngeal Squamous Cell Carcinoma AJCC v7
Stage IV Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
Oropharyngeal p16INK4a-Negative Squamous Cell Carcinoma
Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7
Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7
Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7
Stage IV Oropharyngeal Squamous Cell Carcinoma AJCC v7
Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7
Interventions
Drug: Atezolizumab
Procedure: Biopsy
Biological: Cetuximab
Procedure: Biospecimen Collection
Drug: Cisplatin
Procedure: Computed Tomography
Drug: Docetaxel
Radiation: Intensity-Modulated Radiation Therapy
Other: Laboratory Biomarker Analysis
Procedure: Magnetic Resonance Imaging
Other: Quality-of-Life Assessment
First Posted Date
2013-03-14
Last Posted Date
2025-01-10
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
613
Registration Number
NCT01810913
Locations
🇺🇸

University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States

🇺🇸

The Kirklin Clinic at Acton Road, Birmingham, Alabama, United States

🇺🇸

Banner University Medical Center - Tucson, Tucson, Arizona, United States

and more 319 locations

Docetaxel With or Without Low-dose, Short Course Sunitinib in Refractory Solid Tumors

Phase 2
Conditions
Solid Tumors
Breast Cancer
Non-small Cell Lung Cancer
Prostate Cancer
Gastric Cancer
Interventions
First Posted Date
2013-03-04
Last Posted Date
2016-06-22
Lead Sponsor
National University Hospital, Singapore
Target Recruit Count
80
Registration Number
NCT01803503
Locations
🇸🇬

National University Hospital, Singapore, Singapore

A Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced NSCLC

Phase 3
Terminated
Conditions
Non-Small-Cell Lung Adenocarcinoma
Non-small Cell Lung Cancer Stage IIIB
Non-small Cell Lung Cancer Stage IV
Non-small Cell Lung Cancer Metastatic
Interventions
First Posted Date
2013-02-25
Last Posted Date
2016-07-01
Lead Sponsor
Synta Pharmaceuticals Corp.
Target Recruit Count
696
Registration Number
NCT01798485
Locations
🇺🇸

VA Greater Los Angeles Healthcare System, Los Angeles, California, United States

🇺🇸

Ronald Reagan UCLA Medical Center, Los Angeles, California, United States

🇺🇸

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States

and more 200 locations

Study of Chemotherapy in Combination With IDO Inhibitor in Metastatic Breast Cancer

Phase 2
Completed
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2013-02-15
Last Posted Date
2020-05-28
Lead Sponsor
NewLink Genetics Corporation
Target Recruit Count
169
Registration Number
NCT01792050
Locations
🇵🇱

Research Site, Warsaw, Poland

🇺🇸

University of North Carolina, Chapel Hill, North Carolina, United States

🇺🇸

University of Virginia, Charlottesville, Virginia, United States

and more 28 locations

Safety Study of Afatinib and Postoperative Radiation Therapy to Treat Head and Neck Cancer

Phase 1
Completed
Conditions
Squamous Cell Carcinoma of the Head and Neck
Interventions
Drug: Afatinib
Radiation: Radiation Therapy
Drug: Docetaxel
First Posted Date
2013-02-05
Last Posted Date
2024-03-06
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
38
Registration Number
NCT01783587
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Mount Sinai Medical Center/Icahn School of Medicine at Mount Sinai, New York, New York, United States

🇺🇸

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

Phase 2 Study of Docetaxel +/- OGX-427 in Patients With Relapsed or Refractory Metastatic Bladder Cancer

Phase 2
Completed
Conditions
Bladder Cancer
Urothelial Carcinoma
Interventions
Drug: OGX-427
Drug: Docetaxel
First Posted Date
2013-01-31
Last Posted Date
2022-07-11
Lead Sponsor
Noah Hahn, M.D.
Target Recruit Count
200
Registration Number
NCT01780545
Locations
🇺🇸

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

🇺🇸

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

🇺🇸

Siteman Cancer Center, Saint Louis, Missouri, United States

and more 32 locations
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