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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Multimodality Phase II Study in Prostate Cancer

Phase 2
Terminated
Conditions
Prostate Cancer
Interventions
First Posted Date
2008-08-14
Last Posted Date
2015-12-23
Lead Sponsor
Duke University
Target Recruit Count
36
Registration Number
NCT00734851
Locations
🇺🇸

The Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

🇺🇸

Duke University, Durham, North Carolina, United States

🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

Vandetanib, Oxaliplatin, and Docetaxel in Advanced Cancer of the Esophagus or Gastroesophageal Junction

Phase 1
Terminated
Conditions
Adenocarcinoma of the Gastroesophageal Junction
Esophageal Cancer
Interventions
First Posted Date
2008-08-12
Last Posted Date
2011-08-22
Lead Sponsor
Case Comprehensive Cancer Center
Target Recruit Count
9
Registration Number
NCT00732745
Locations
🇺🇸

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

Docetaxel and Cetuximab in Treating Patients With Metastatic Prostate Cancer

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
Biological: cetuximab
Drug: docetaxel
First Posted Date
2008-08-06
Last Posted Date
2019-05-14
Lead Sponsor
Swiss Group for Clinical Cancer Research
Target Recruit Count
35
Registration Number
NCT00728663
Locations
🇨🇭

Kantonspital Aarau, Aarau, Switzerland

🇨🇭

AndreasKlinik Cham Zug, Cham, Switzerland

🇨🇭

Spitalzentrum Biel, Biel, Switzerland

and more 18 locations

Docetaxel, Cisplatin, and Fluorouracil Followed By Cetuximab and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer

Phase 2
Completed
Conditions
Head and Neck Cancer
Interventions
Biological: cetuximab
Drug: cisplatin
Drug: docetaxel
Drug: fluorouracil
Procedure: computed tomography
Procedure: positron emission tomography
Procedure: quality-of-life assessment
Radiation: 3-dimensional conformal radiation therapy
Radiation: intensity-modulated radiation therapy
First Posted Date
2008-07-24
Last Posted Date
2020-04-07
Lead Sponsor
Wake Forest University Health Sciences
Target Recruit Count
20
Registration Number
NCT00721513
Locations
🇺🇸

Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States

Erlotinib, Docetaxel, and Radiation Therapy in Stage III or Stage IV Squamous Cell Carcinoma of the Head and Neck

Phase 2
Completed
Conditions
Head and Neck Cancer
Interventions
Drug: docetaxel
Drug: erlotinib hydrochloride
Genetic: fluorescence in situ hybridization
Genetic: polymerase chain reaction
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Other: pharmacological study
Procedure: therapeutic conventional surgery
Radiation: intensity-modulated radiation therapy
Radiation: radiation therapy
First Posted Date
2008-07-22
Last Posted Date
2024-08-22
Lead Sponsor
Case Comprehensive Cancer Center
Target Recruit Count
43
Registration Number
NCT00720304
Locations
🇺🇸

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

Postoperative Chemotherapy and Chemo-radiotherapy for Resected Gastric Cancer

Phase 2
Completed
Conditions
Gastric Cancer
Interventions
First Posted Date
2008-07-21
Last Posted Date
2015-05-18
Lead Sponsor
Hellenic Oncology Research Group
Target Recruit Count
40
Registration Number
NCT00718913
Locations
🇬🇷

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

🇬🇷

University Hospital of Crete Dept of Medical Oncology, Heraklion, Crete, Greece

🇬🇷

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

and more 5 locations

Phase II Study of Docetaxel for Clinically Asymptomatic High Risk Prostate Cancer Patients

Phase 2
Terminated
Conditions
Prostate Cancer
Interventions
First Posted Date
2008-07-14
Last Posted Date
2012-10-31
Lead Sponsor
CHU de Quebec-Universite Laval
Target Recruit Count
6
Registration Number
NCT00714376
Locations
🇨🇦

Centre de recherche clinique et evaluative en oncologie, L'Hôtel-Dieu de Québec-CHUQ, Quebec, Canada

Bortezomib (PS-341) in Combination With Carboplatin and Docetaxel for Patients With Advanced Non-Small Cell Lung Cancer

Phase 1
Terminated
Conditions
Non Small Cell Lung Cancer
Interventions
First Posted Date
2008-07-14
Last Posted Date
2019-06-24
Lead Sponsor
Milton S. Hershey Medical Center
Target Recruit Count
6
Registration Number
NCT00714246
Locations
🇺🇸

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States

Combination Therapy With MYOCET® (Doxorubicin HCL Liposome for Injection) in Participants With HER2-Positive Breast Cancer

First Posted Date
2008-07-10
Last Posted Date
2024-02-23
Lead Sponsor
Cephalon, Inc.
Target Recruit Count
126
Registration Number
NCT00712881
Locations
🇩🇪

Teva Investigational Site 30, Aachen, Germany

🇧🇪

Teva Investigational Site 9, Brussels, Belgium

🇦🇹

Teva Investigational Site 15, Wien, Austria

and more 19 locations

Study Of SU011248 In Combination With Docetaxel In Patients With Advanced Cancer

Phase 1
Completed
Conditions
Advanced Solid Tumors
Non Small Cell Lung Cancer
Interventions
First Posted Date
2008-07-10
Last Posted Date
2008-11-11
Lead Sponsor
Pfizer
Target Recruit Count
49
Registration Number
NCT00712504
Locations
🇺🇸

Pfizer Investigational Site, Madison, Wisconsin, United States

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