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
-

Study of Nab-Paclitaxel in High Risk Early Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2012-09-24
Last Posted Date
2021-02-02
Lead Sponsor
German Breast Group
Target Recruit Count
2886
Registration Number
NCT01690702
Locations
🇩🇪

Klinikum Frankfurt Höchst, Frankfurt, Hessen, Germany

Imaging for Response Assessment of Neoadjuvant Chemotherapy in Primary Breast Cancer (GALADON)

First Posted Date
2012-09-21
Last Posted Date
2018-08-13
Lead Sponsor
West German Study Group
Target Recruit Count
21
Registration Number
NCT01690325
Locations
🇩🇪

Breast Centre, University of Munich, LMU, Munich, Bavaria, Germany

Cabozantinib Plus Docetaxel and Prednisone for Advanced Prostate Cancer

Phase 1
Completed
Conditions
Prostatic Neoplasms
Interventions
First Posted Date
2012-09-12
Last Posted Date
2019-11-08
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
49
Registration Number
NCT01683994
Locations
🇺🇸

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

Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC

Phase 3
Completed
Conditions
Non-Squamous Cell Non-small Cell Lung Cancer
Interventions
Biological: Nivolumab
Drug: Docetaxel
First Posted Date
2012-08-28
Last Posted Date
2023-02-08
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
582
Registration Number
NCT01673867
Locations
🇺🇸

Local Institution - 0035, Sayre, Pennsylvania, United States

🇧🇷

Local Institution - 0054, Salvador, Bahia, Brazil

🇺🇸

Local Institution - 0033, Dallas, Texas, United States

and more 84 locations

Docetaxel +/- Suramin in 2nd Line Advanced Non-Small Cell Lung Cancer

Phase 2
Completed
Conditions
Carcinoma, Non Small Cell Lung
Interventions
First Posted Date
2012-08-23
Last Posted Date
2020-05-12
Lead Sponsor
University of Wisconsin, Madison
Target Recruit Count
80
Registration Number
NCT01671332
Locations
🇺🇸

University of Wisconsin Carbone Comprehensive Cancer Center, Madison, Wisconsin, United States

🇺🇸

Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Clinical Trial of Boanmycin Hydrochloride With Docetaxel for Patients With Lung Squamous Cell Cancer as Chemotherapy

Phase 2
Conditions
Squamous Cell Lung Cancer
Interventions
First Posted Date
2012-08-08
Last Posted Date
2015-12-22
Lead Sponsor
Tianjin Medical University Cancer Institute and Hospital
Target Recruit Count
300
Registration Number
NCT01660399
Locations
🇨🇳

Department of Pulmonary Medical Oncology, Tianjin Medical University Cancer Hospital, Tianjin, Tianjin, China

Phase II Study of Docetaxel +/- Nintedanib in Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2012-08-07
Last Posted Date
2019-05-31
Lead Sponsor
Centre Oscar Lambret
Target Recruit Count
51
Registration Number
NCT01658462
Locations
🇫🇷

Centre Alexis Vautrin, Vandoeuvre Les Nancy, France

🇫🇷

Centre Léonard de Vinci, Dechy, France

🇫🇷

Institut Jean Godinot, Reims, France

and more 9 locations

CP-751,871 In Combination With Docetaxel In Advance Non-hematologic Malignancies

Phase 1
Completed
Conditions
Advanced Non-Hematologic Malignancies
Interventions
Drug: CP-751,871
Drug: Docetaxel
First Posted Date
2012-07-30
Last Posted Date
2013-10-30
Lead Sponsor
Pfizer
Target Recruit Count
46
Registration Number
NCT01653158
Locations
🇬🇧

Pfizer Investigational Site, Sutton, Surrey, United Kingdom

Testing of Drugs Erlotinib and Docetaxel in Lung Cancer Patients Classified Regarding Their Outlook Using VeriStrat®.

Phase 3
Completed
Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
First Posted Date
2012-07-30
Last Posted Date
2022-08-24
Lead Sponsor
ETOP IBCSG Partners Foundation
Target Recruit Count
81
Registration Number
NCT01652469
Locations
🇦🇹

Krankenhaus Hietzing, Wien, Austria

🇭🇺

National Institute of Oncology, Budapest, Hungary

🇮🇪

St James's Hospital, Dublin, Ireland

and more 29 locations

An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations

Phase 2
Terminated
Conditions
Advanced Non Small Cell Lung Cancer (NSCLC)
Interventions
First Posted Date
2012-07-20
Last Posted Date
2019-07-24
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
59
Registration Number
NCT01646125
Locations
🇺🇸

Cedars Sinai Medical Center Dept.of Cedars-Sinai Med. Ctr., Los Angeles, California, United States

🇬🇧

Novartis Investigative Site, Leicester, United Kingdom

🇺🇸

Maryland Oncology Hematology, P.A. SC, Rockville, Maryland, United States

and more 1 locations
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