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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Docetaxel/Cisplatin/5-Fluorouracil (TPF) Human Papillomavirus (HPV) Squamous Cell Carcinoma Study

Phase 2
Terminated
Conditions
Squamous Cell Carcinoma of the Head and Neck
Human Papilloma Virus
Interventions
First Posted Date
2010-10-15
Last Posted Date
2017-12-06
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
7
Registration Number
NCT01221753
Locations
🇺🇸

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

Evaluation of an Anti-cancer Immunotherapy Combined With Standard Neoadjuvant Treatment in Patients With WT1-positive Primary Invasive Breast Cancer

Phase 2
Terminated
Conditions
Neoplasms, Breast
Interventions
Biological: GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK2302024A
Drug: Placebo
Drug: Aromatase inhibitor
Drug: Carboplatin AUC
Drug: 5-Fluorouracil
Drug: Docetaxel
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Epirubicin
Drug: Paclitaxel
Drug: Trastuzumab
First Posted Date
2010-10-13
Last Posted Date
2021-05-25
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
66
Registration Number
NCT01220128
Locations
🇬🇧

GSK Investigational Site, Nottingham, United Kingdom

Trimodality Management of T1b Esophageal Cancers

Phase 1
Completed
Conditions
Esophageal Cancer
Interventions
Drug: Docetaxel
Drug: 5-FU
Radiation: Radiotherapy
Procedure: Esophagectomy
Drug: Dexamethasone
First Posted Date
2010-10-08
Last Posted Date
2021-04-13
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
4
Registration Number
NCT01217060
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

5-FU, Leucovorin, Oxaliplatin and Docetaxel (FLOT) Versus Epirubicin, Cisplatin and 5-FU (ECF) in Patients With Locally Advanced, Resectable Gastric Cancer

First Posted Date
2010-10-07
Last Posted Date
2019-06-19
Lead Sponsor
Krankenhaus Nordwest
Target Recruit Count
716
Registration Number
NCT01216644
Locations
🇩🇪

Krankenhaus Nordwest, Frankfurt, Germany

Residual Hypermethylation in Early Stage Non-Small Cell Lung Cancer (NSCLC) As Part of Adjuvant Therapy and Preventive Strategy

Not Applicable
Completed
Conditions
Lung Cancer
Hypermethylation
Non Small Cell Lung Carcinoma
Interventions
Drug: Cisplatin
Drug: Carboplatin
Drug: Paclitaxel
Drug: Vidaza
Procedure: Tumor Specimen for Methylation Analysis
Procedure: Blood Sample for Methylation Analysis
Drug: Vinorelbine
Drug: Docetaxel
Drug: Pemetrexed
First Posted Date
2010-09-27
Last Posted Date
2015-02-24
Lead Sponsor
University of Miami
Target Recruit Count
6
Registration Number
NCT01209520
Locations
🇺🇸

University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, United States

Amrubicin (AMR) Trial in Patients With Non-small Cell Lung Cancer

Phase 3
Completed
Conditions
Lung Cancer
Interventions
First Posted Date
2010-09-22
Last Posted Date
2022-04-12
Lead Sponsor
Sumitomo Pharma Co., Ltd.
Target Recruit Count
202
Registration Number
NCT01207011
Locations
🇯🇵

32 Sites, Multiple Locations, Japan

CESAR Study in Prostate Cancer With Temsirolimus Added to Standard Docetaxel Therapy (CEPTAS)

Phase 1
Completed
Conditions
Prostatic Neoplasms
First Posted Date
2010-09-21
Last Posted Date
2016-01-27
Lead Sponsor
Central European Society for Anticancer Drug Research
Target Recruit Count
19
Registration Number
NCT01206036
Locations
🇩🇪

CESAR Study Center, Freiburg, Germany

Study of PX-866 and Docetaxel in Solid Tumors

Phase 1
Completed
Conditions
Non Small Cell Lung Cancer (NSCLC)
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Interventions
Drug: Docetaxel
Drug: PX-866
First Posted Date
2010-09-17
Last Posted Date
2018-05-16
Lead Sponsor
Cascadian Therapeutics Inc.
Target Recruit Count
223
Registration Number
NCT01204099
Locations
🇺🇸

University of Pennsylvania, Philadelphia, Pennsylvania, United States

🇨🇦

CHUS Hopital Fleurimont, Sherbrooke, Quebec, Canada

🇺🇸

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

and more 30 locations

A Study of Erlotinib [Tarceva] as Monotherapy or Intermittent Dosing With Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer. (TALISMAN)

Phase 2
Completed
Conditions
Non-Squamous Non-Small Cell Lung Cancer
Interventions
First Posted Date
2010-09-17
Last Posted Date
2015-11-16
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
74
Registration Number
NCT01204697

Temsirolimus, Carboplatin, and Paclitaxel as First-Line Therapy in Treating Patients With Newly Diagnosed Stage III-IV Clear Cell Ovarian Cancer

Phase 2
Completed
Conditions
Ovarian Clear Cell Cystadenocarcinoma
Stage III Ovarian Cancer
Stage IV Ovarian Cancer
Interventions
First Posted Date
2010-09-08
Last Posted Date
2019-08-08
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
90
Registration Number
NCT01196429
Locations
🇺🇸

Cadence Cancer Center in Warrenville, Warrenville, Illinois, United States

🇺🇸

Lahey Hospital and Medical Center, Burlington, Massachusetts, United States

🇺🇸

Case Western Reserve University, Cleveland, Ohio, United States

and more 142 locations
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