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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A Study of Docetaxel Monotherapy or DOXIL and Docetaxel in Patients With Advanced Breast Cancer

Phase 3
Completed
Conditions
Interventions
First Posted Date
2004-09-13
Last Posted Date
2014-04-21
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
751
Registration Number
NCT00091442

Comparison of Combination Chemotherapy Regimens in Treating Patients With Advanced Stomach Cancer

Phase 2
Completed
Conditions
First Posted Date
2004-09-06
Last Posted Date
2013-06-21
Lead Sponsor
Eastern Cooperative Oncology Group
Registration Number
NCT00003172
Locations
🇺🇸

CCOP - Marshfield Medical Research and Education Foundation, Marshfield, Wisconsin, United States

🇺🇸

University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States

🇺🇸

CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center, Tulsa, Oklahoma, United States

and more 22 locations

Docetaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer

Phase 1
Conditions
First Posted Date
2004-09-02
Last Posted Date
2014-01-06
Lead Sponsor
Herbert Irving Comprehensive Cancer Center
Target Recruit Count
37
Registration Number
NCT00002775
Locations
🇺🇸

Herbert Irving Comprehensive Cancer Center, New York, New York, United States

Second-Line Treatment for Patients With Platinum-Sensitive Ovarian Cancer

Phase 2
Completed
Conditions
Interventions
First Posted Date
2004-08-31
Last Posted Date
2015-02-25
Lead Sponsor
Duke University
Target Recruit Count
150
Registration Number
NCT00090610
Locations
🇺🇸

Franklin Square Hospital Center/MedStar Health-Section of Hematology/Oncology, Baltimore, Maryland, United States

🇺🇸

Hope: A Woman's Cancer Center, Asheville, North Carolina, United States

🇺🇸

Columbia University College of Physicians and Surg, New York, New York, United States

and more 16 locations

Combination Chemotherapy in Treating Women With Breast Cancer

Phase 3
Completed
Conditions
First Posted Date
2004-08-26
Last Posted Date
2023-06-15
Lead Sponsor
Eastern Cooperative Oncology Group
Target Recruit Count
2778
Registration Number
NCT00003519
Locations
🇺🇸

USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States

🇺🇸

Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, United States

🇺🇸

University of Chicago Cancer Research Center, Chicago, Illinois, United States

and more 131 locations

Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast Cancer

Phase 2
Completed
Conditions
First Posted Date
2004-08-23
Last Posted Date
2013-05-30
Lead Sponsor
Hackensack Meridian Health
Registration Number
NCT00004906
Locations
🇺🇸

University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States

🇺🇸

Ireland Cancer Center, Cleveland, Ohio, United States

🇺🇸

Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States

and more 1 locations

Docetaxel, Thalidomide, Prednisone, and Bevacizumab to Treat Metastatic Prostate Cancer

First Posted Date
2004-08-09
Last Posted Date
2018-04-20
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
73
Registration Number
NCT00089609
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Phase III Trial Of Docetaxel Versus Docetaxel Plus ZD1839 In Head And Neck Cancer

First Posted Date
2004-08-05
Last Posted Date
2015-05-06
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
270
Registration Number
NCT00088907
Locations
🇺🇸

Eastern Cooperative Oncology Group, Boston, Massachusetts, United States

Docetaxel, Capecitabine, and Bevacizumab in Treating Patients With Metastatic Breast Cancer

First Posted Date
2004-08-05
Last Posted Date
2016-12-07
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
46
Registration Number
NCT00088998
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