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
-

Docetaxel and S-1 Followed By Radiation Therapy and Low-Dose Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer

Phase 2
Conditions
Head and Neck Cancer
First Posted Date
2008-02-29
Last Posted Date
2011-02-28
Lead Sponsor
Yonsei University
Target Recruit Count
46
Registration Number
NCT00625937
Locations
🇰🇷

Yonsei Cancer Center at Yonsei University Medical Center, Seoul, Korea, Republic of

Cetuximab as Induction Treatment in Head and Neck Squamous Cell Carcinoma (HNSCC)

Phase 2
Completed
Conditions
Head and Neck Neoplasm
Interventions
First Posted Date
2008-02-26
Last Posted Date
2013-12-04
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
92
Registration Number
NCT00623558
Locations
🇰🇷

Seoul National University Hospital, Seoul, Korea, Republic of

Cisplatin/Vinorelbine/Bevacizumab Followed by Docetaxel/Gemcitabine/Bevacizumab Versus the Cisplatin/Docetaxel/Bevacizumab Combination in Locally Advanced or Metastatic NSCLC

Phase 2
Completed
Conditions
Non Small Cell Lung Cancer
Interventions
First Posted Date
2008-02-22
Last Posted Date
2014-06-25
Lead Sponsor
Hellenic Oncology Research Group
Target Recruit Count
77
Registration Number
NCT00620971
Locations
🇬🇷

Sismanogleio General Hospital, 1st, 2nd Dep of Pulmonary Diseases, Athens, Greece

🇬🇷

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine, Athens, Greece

🇬🇷

IASO" General Hospital of Athens, 1st Dep of Medical Oncology, Athens, Greece

and more 6 locations

To Determine the Objective Response Rate of 4 Cycles of Docetaxel + Anthracycline (Epirubicin or Doxorubicine) Followed by 4 Cycles of Docetaxel Single Agent

Phase 2
Terminated
Conditions
Breast Neoplasms
First Posted Date
2008-02-21
Last Posted Date
2009-06-03
Lead Sponsor
Sanofi
Target Recruit Count
2
Registration Number
NCT00620100
Locations
🇦🇹

Sanofi-Aventis, Vienna, Austria

🇵🇱

Sanofi-aventis, Warsaw, Poland

Study of Sorafenib and Docetaxel in Metastatic Prostate Cancer

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2008-02-21
Last Posted Date
2009-02-26
Lead Sponsor
Italian Trial in Medical Oncology
Target Recruit Count
43
Registration Number
NCT00619996
Locations
🇮🇹

Dipartimento di Oncologia, dei Trapianti e delle Nuove Tecnologie in Medicina ... Indirizzo: via Roma, 55 - 56100 Pisa Tel. 050-2218690 - Fax. 050-2218685, Pisa, Italy

A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer

Phase 3
Completed
Conditions
Prostate Cancer
Interventions
Drug: Docetaxel
Drug: Placebo
Drug: ZD4054
First Posted Date
2008-02-18
Last Posted Date
2012-09-10
Lead Sponsor
AstraZeneca
Target Recruit Count
1494
Registration Number
NCT00617669
Locations
🇬🇧

Research Site, Manchester, United Kingdom

Study to Evaluate Treatment Customized According to RAP80 and BRCA1 in Patients With Advanced Lung Carcinoma

Phase 3
Terminated
Conditions
BRCA1 Mutation
Non Small Cell Lung Cancer
Interventions
First Posted Date
2008-02-18
Last Posted Date
2024-01-30
Lead Sponsor
Spanish Lung Cancer Group
Target Recruit Count
382
Registration Number
NCT00617656
Locations
🇪🇸

H. Gen. Univ. Valencia, Valencia, Spain

🇪🇸

H. General de Vic, Vic, Spain

🇪🇸

Hospital de La Santa Creu I Sant Pau, Barcelona, Spain

and more 41 locations

GETNA2 Neoadj. TAX+Femara vs Femara in g I/II Breast Cancer

Phase 2
Completed
Conditions
Breast Neoplasms
First Posted Date
2008-02-18
Last Posted Date
2009-09-02
Lead Sponsor
Sanofi
Target Recruit Count
5
Registration Number
NCT00617968
Locations
🇫🇷

Sanofi-Aventis, Paris, France

Six vs 12 Months of Trastuzumab With Docetaxel Following FEC as Adjuvant Treatment in N+ Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
Interventions
Drug: Docetaxel
Drug: Trastuzumab
Drug: Epirubicin
Drug: Cyclophosphamide
Drug: Granulocyte-colony stimulating growth factor
Drug: 5-fluoruracil
First Posted Date
2008-02-14
Last Posted Date
2015-03-04
Lead Sponsor
Hellenic Oncology Research Group
Target Recruit Count
489
Registration Number
NCT00615602
Locations
🇬🇷

University Hospital of Crete, Heraklion, Crete, Greece

🇬🇷

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine, Athens, Greece

🇬🇷

University General Hospital of Alexandroupolis, Dep of Medical Oncology, Alexandroupolis, Greece

and more 7 locations

Perioperative Therapy for Resectable Pancreatic Cancer

Phase 2
Completed
Conditions
Adenocarcinoma of the Pancreas
Stage IA Pancreatic Cancer
Stage IB Pancreatic Cancer
Stage IIA Pancreatic Cancer
Stage IIB Pancreatic Cancer
Interventions
Drug: gemcitabine hydrochloride
Drug: docetaxel
Drug: capecitabine
Radiation: intensity-modulated radiation therapy
Drug: oxaliplatin
Procedure: pancreatic surgical procedure
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
First Posted Date
2008-02-07
Last Posted Date
2017-07-13
Lead Sponsor
University of Washington
Target Recruit Count
35
Registration Number
NCT00609336
Locations
🇺🇸

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

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