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
-

Hormonal Ablation, Imatinib Mesylate and Docetaxel for Patients With Prostate Cancer

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2007-07-12
Last Posted Date
2015-04-28
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
39
Registration Number
NCT00500110
Locations
🇺🇸

U.T.M.D. Anderson Cancer Center, Houston, Texas, United States

Phase III of RRM1 & ERCC1 Directed Customized Chemotherapy for the Treatment of Patients With NSCLC

Phase 3
Completed
Conditions
Non-Small Cell Lung Cancer
Interventions
First Posted Date
2007-07-11
Last Posted Date
2014-07-09
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
275
Registration Number
NCT00499109
Locations
🇺🇸

Leesburg Regional Medical Center, Leesburg, Florida, United States

🇺🇸

Center for Cancer Care & Research/Watson, Lakeland, Florida, United States

🇺🇸

Johns Hopkins Sidney Kimmell Comprehensive Cancer Center, Baltimore, Maryland, United States

and more 6 locations

NOV-002, Doxorubicin, Cyclophosphamide, and Docetaxel in Women With Newly Diagnosed Stage II or IIIC Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2007-07-11
Last Posted Date
2018-01-02
Lead Sponsor
University of Miami
Target Recruit Count
41
Registration Number
NCT00499122
Locations
🇺🇸

Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States

🇺🇸

University of Miami, Miami, Florida, United States

Combination Chemotherapy and Radiation Therapy With or Without Lapatinib in Treating Patients With Locally Advanced Cancer of the Larynx or Hypopharynx

Phase 1
Completed
Conditions
Head and Neck Cancer
First Posted Date
2007-07-11
Last Posted Date
2018-07-09
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Target Recruit Count
7
Registration Number
NCT00498953
Locations
🇧🇪

Institut Jules Bordet, Brussels, Belgium

E3-Hormone Refractory Prostrate Cancer Taxotere Combination

Phase 2
Completed
Conditions
Prostate Cancer
Metastatic
Hormone Refractory
First Posted Date
2007-07-10
Last Posted Date
2016-10-07
Lead Sponsor
Sanofi
Target Recruit Count
86
Registration Number
NCT00498797
Locations
🇸🇪

Research Site, Uppsala, Sweden

🇧🇷

Research site, Rio de Janeiro, Brazil

Phase II Trial of Docetaxel and Celecoxib in Patients With Androgen Independent Prostate Cancer

Phase 2
Terminated
Conditions
Metastatic Prostate Cancer
First Posted Date
2007-06-29
Last Posted Date
2009-10-01
Lead Sponsor
Sanofi
Target Recruit Count
6
Registration Number
NCT00494338
Locations
🇧🇷

Sanofi-Aventis, Sao Paulo, Brazil

E3 Breast Cancer Taxotere Combination

Phase 2
Completed
Conditions
Advanced Breast Cancer
Interventions
First Posted Date
2007-06-29
Last Posted Date
2016-09-30
Lead Sponsor
Genzyme, a Sanofi Company
Target Recruit Count
64
Registration Number
NCT00494481
Locations
🇪🇸

Research SIte, Lérida, Spain

🇨🇳

Research Site, Taipei, Taiwan

TAC Versus TC for Adjuvant Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2007-06-28
Last Posted Date
2023-03-02
Lead Sponsor
US Oncology Research
Target Recruit Count
1961
Registration Number
NCT00493870
Locations
🇺🇸

Texas Cancer Center at Medical City, Dallas, Texas, United States

🇺🇸

Chattanooga Oncology & Hematology Associates, PC, Chattanooga, Tennessee, United States

🇺🇸

Hematology Oncology Associates of IL, Chicago, Illinois, United States

and more 88 locations

A Phase II Combination of Trastuzumab and Ixabepilone Versus Trastuzumab and Docetaxel in Patients With Advanced and/or Metastatic Breast Cancer

Phase 2
Completed
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2007-06-25
Last Posted Date
2016-03-10
Lead Sponsor
R-Pharm
Target Recruit Count
50
Registration Number
NCT00490646
Locations
🇹🇷

Local Institution, Izmir, Turkey

Intermittent Chemotherapy With or Without Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) for Metastatic Hormone Refractory Prostate Cancer (HRPC)

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2007-06-20
Last Posted Date
2019-11-20
Lead Sponsor
University of California, San Francisco
Target Recruit Count
125
Registration Number
NCT00488982
Locations
🇺🇸

University of Washington, Seattle, Washington, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

University of California, San Francisco, San Francisco, California, United States

and more 1 locations
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