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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NEOadjuvant Trial in Adenocarcinoma of the oEsophagus and oesophagoGastric Junction International Study (Neo-AEGIS)

Phase 3
Completed
Conditions
Adenocarcinoma of the Oesophagus
Oesophageal Tumours
Junctional Tumours
Adenocarcinoma of the Oesophago-gastric Junction
Oesophageal Cancer
Interventions
First Posted Date
2012-11-15
Last Posted Date
2022-09-30
Lead Sponsor
Cancer Trials Ireland
Target Recruit Count
377
Registration Number
NCT01726452
Locations
🇬🇧

Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Box 279(s4), Cambridge Biomedical Camp, Cambridge, United Kingdom

🇸🇪

Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden

🇬🇧

Nottingham City Hospital, Nottingham University Hospitals NHS Trust, Hucknall Road, Nottingham, United Kingdom

and more 26 locations

Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer

Phase 2
Completed
Conditions
Neutropenia
Interventions
First Posted Date
2012-11-12
Last Posted Date
2022-04-15
Lead Sponsor
Spectrum Pharmaceuticals, Inc
Target Recruit Count
148
Registration Number
NCT01724866
Locations
🇺🇸

California Cancer Associates for Research and Excellence, Los Angeles, California, United States

🇺🇸

Beaver Medical Group, Highland, California, United States

🇺🇸

Innovative Clinical Research Institute, Whittier, California, United States

and more 23 locations

Docetaxel, Gemcitabine and Pazopanib as Treatment for Soft Tissue Sarcoma

Phase 1
Completed
Conditions
Stage III Adult Soft Tissue Sarcoma
Interventions
First Posted Date
2012-11-01
Last Posted Date
2016-06-16
Lead Sponsor
University of Vermont
Target Recruit Count
6
Registration Number
NCT01719302
Locations
🇺🇸

Fletcher Allen Health Care, Burlington, Vermont, United States

Phase II Study Using CHFR Methylation Status in Patients With Metastatic Esophageal, Gastroesophageal, Gastric Cancer.

Phase 2
Completed
Conditions
Gastroesophageal Cancer
Gastric Cancer
Metastatic Esophageal Cancer
Interventions
First Posted Date
2012-10-26
Last Posted Date
2019-03-15
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Target Recruit Count
27
Registration Number
NCT01715233
Locations
🇺🇸

SKCCC at Johns Hopkins, Baltimore, Maryland, United States

A Clinical Study on the Safety and Efficacy of Debio 0932 in Combination With Standard of Care in Patients With Non-small Cell Lung Cancer [NSCLC]

Phase 1
Terminated
Conditions
Non-small Cell Lung Cancer
Interventions
First Posted Date
2012-10-25
Last Posted Date
2015-04-08
Lead Sponsor
Debiopharm International SA
Target Recruit Count
82
Registration Number
NCT01714037
Locations
🇫🇷

Centre GF Leclerc, Dijon, France

🇫🇷

Institut de Cancérologie de l'Ouest- Institut René Gauduchau, Nantes, France

🇫🇷

Centre Léon Bérard, Lyon, France

and more 5 locations

Salvage Docetaxel for Pretreated Urothelial Cancer

Phase 2
Completed
Conditions
Bladder Cancer
Interventions
First Posted Date
2012-10-22
Last Posted Date
2014-05-15
Lead Sponsor
Samsung Medical Center
Target Recruit Count
31
Registration Number
NCT01711112
Locations
🇰🇷

Samsung Medical Center, Seoul, Gangnam-gu, Korea, Republic of

A Phase II Trial of Epirubicin, Oxaliplatin and Capecitabine (EOX) Versus Docetaxel and Oxaliplatin (ElTax) in the Treatment of Advanced Gastro-oesophageal Cancer

Phase 2
Completed
Conditions
Gastro Oesophageal Cancer
Interventions
First Posted Date
2012-10-19
Last Posted Date
2013-01-10
Lead Sponsor
Cancer Trials Ireland
Target Recruit Count
35
Registration Number
NCT01710592
Locations
🇮🇪

Mercy University Hospital, Cork, Ireland

🇮🇪

Beaumont Hospital, Dublin, Ireland

🇮🇪

Mater Misericordiae University hospital & Mater Private Hospital, Dublin, Ireland

and more 3 locations

Reolysin in Previously Treated Advanced/Metastatic, Non Small Cell Lung Cancer Receiving Standard Salvage Therapy

First Posted Date
2012-10-17
Last Posted Date
2023-08-04
Lead Sponsor
Canadian Cancer Trials Group
Target Recruit Count
166
Registration Number
NCT01708993
Locations
🇨🇦

Lakeridge Health Oshawa, Oshawa, Ontario, Canada

🇨🇦

Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

🇨🇦

Tom Baker Cancer Centre, Calgary, Alberta, Canada

and more 9 locations

A Phase 1, Dose Escalation Study to Assess the Safety and Tolerability of ASP9853 With Either Docetaxel or Paclitaxel in Patients With Advanced Non-hematologic Malignancies

Phase 1
Terminated
Conditions
Pharmacokinetics of ASP9853
Non-hematologic Malignancies
Interventions
First Posted Date
2012-10-12
Last Posted Date
2024-11-07
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
21
Registration Number
NCT01705483
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

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

🇺🇸

Barbara Ann Karmanos Cancer Center, Detroit, Michigan, United States

and more 1 locations

A Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer

Phase 2
Completed
Conditions
Non-small Cell Lung Cancer Metastatic
Interventions
First Posted Date
2012-10-10
Last Posted Date
2019-09-30
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
197
Registration Number
NCT01703091
Locations
🇯🇵

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Yamaguchi, Japan

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