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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Concurrent Helical Tomotherapy With Chemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)

Phase 1
Conditions
Non-Small-Cell Lung Carcinoma
First Posted Date
2006-09-22
Last Posted Date
2008-03-13
Lead Sponsor
AZ-VUB
Target Recruit Count
30
Registration Number
NCT00379717
Locations
🇧🇪

UZ Brussel, Jette, Belgium

Epirubicin and Cyclophosphamide Followed By Docetaxel and Trastuzumab in Treating Women With HER2-Positive Stage III or Stage IV Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
Biological: trastuzumab
Drug: cyclophosphamide
Drug: docetaxel
Drug: epirubicin hydrochloride
Procedure: conventional surgery
Procedure: neoadjuvant therapy
First Posted Date
2006-09-21
Last Posted Date
2016-09-28
Lead Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Target Recruit Count
38
Registration Number
NCT00379015
Locations
🇯🇵

Niigata Cancer Center Hospital, Niigata, Japan

🇯🇵

Shikoku Cancer Center, Matsuyama-shi, Ehime, Japan

🇯🇵

National Kyushu Cancer Center, Fukuoka-shi, Fukuoka, Japan

and more 2 locations

Phase I Trial of Docetaxel and Low-Dose Fractionated Radiation in the Treatment of Metastatic or Recurrent NSCLC

Phase 1
Terminated
Conditions
Non-Small Cell Lung Cancer
Interventions
Drug: Docetaxel
Radiation: Radiation
First Posted Date
2006-09-20
Last Posted Date
2015-06-08
Lead Sponsor
Susanne Arnold
Target Recruit Count
10
Registration Number
NCT00378404
Locations
🇺🇸

University of Kentucky, Lexington, Kentucky, United States

Multicenter Evaluation of Docetaxel, Gemcitabine, and Bevacizumab Combination Followed by Bevacizumab Alone in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Phase 2
Terminated
Conditions
Non-small Cell Lung Cancer
Interventions
First Posted Date
2006-09-20
Last Posted Date
2010-01-26
Lead Sponsor
Sanofi
Target Recruit Count
17
Registration Number
NCT00378573
Locations
🇺🇸

Sanofi-Aventis Administrative Office, Bridgewater, New Jersey, United States

Docetaxel Compared With Observation in Treating Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer

Phase 3
Conditions
Prostate Cancer
First Posted Date
2006-09-15
Last Posted Date
2013-08-26
Lead Sponsor
Scandinavian Prostate Cancer Group
Target Recruit Count
396
Registration Number
NCT00376792
Locations
🇸🇪

Lund University Hospital, Lund, Sweden

🇩🇰

Aarhus Universitetshospital - Aarhus Sygehus, Aarhus, Denmark

🇸🇪

Malmo University Hospital, Malmo, Sweden

and more 5 locations

AEG35156 and Docetaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Solid Tumors

Phase 1
Completed
Conditions
Unspecified Adult Solid Tumor, Protocol Specific
First Posted Date
2006-09-07
Last Posted Date
2023-08-04
Lead Sponsor
NCIC Clinical Trials Group
Target Recruit Count
27
Registration Number
NCT00372736
Locations
🇨🇦

BCCA - Vancouver Cancer Centre, Vancouver, British Columbia, Canada

🇨🇦

McGill University - Dept. Oncology, Montreal, Quebec, Canada

🇨🇦

Univ. Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada

Therapy With Bevacizumab (BEV), Doxorubicin, and Cyclophosphamide Followed by BEV, Docetaxel, and Capecitabine Before Surgery Followed by BEV Alone After Surgery for Women With Locally Advanced Breast Cancer

First Posted Date
2006-08-17
Last Posted Date
2021-04-13
Lead Sponsor
NSABP Foundation Inc
Target Recruit Count
45
Registration Number
NCT00365417
Locations
🇺🇸

NSABP Foundation, Inc., Pittsburgh, Pennsylvania, United States

Pilot Study of Docetaxel & Bevacizumab +/- Trastuzumab in First-Line Treatment of Patients With Metastatic Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2006-08-15
Last Posted Date
2012-08-23
Lead Sponsor
Sanofi
Target Recruit Count
73
Registration Number
NCT00364611
Locations
🇺🇸

Sanofi-Aventis Administrative Office, Bridgewater, New Jersey, United States

Docetaxel and Bortezomib in Treating Patients With Progressive or Recurrent Non-Small Cell Lung Cancer

Phase 2
Completed
Conditions
Non-small Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Interventions
Drug: docetaxel
Drug: bortezomib
Other: laboratory biomarker analysis
Other: immunoenzyme technique
Other: immunohistochemistry staining method
Other: pharmacological study
First Posted Date
2006-08-15
Last Posted Date
2017-12-05
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
81
Registration Number
NCT00362882
Locations
🇺🇸

City of Hope Medical Center, Duarte, California, United States

Oxaliplatin, Docetaxel, and Radiation Therapy in Treating Patients With Unresectable Stage II/III or Recurrent NSCLC

Phase 1
Terminated
Conditions
Lung Cancer
Interventions
Drug: docetaxel
Drug: oxaliplatin
Procedure: radiation therapy
First Posted Date
2006-07-27
Last Posted Date
2017-11-29
Lead Sponsor
Masonic Cancer Center, University of Minnesota
Target Recruit Count
4
Registration Number
NCT00356941
Locations
🇺🇸

University of Minnesota Cancer Center, Minneapolis, Minnesota, United States

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