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

Epirubicin and Tamoxifen With or Without Docetaxel in Treating Postmenopausal Women With Breast Cancer

Phase 3
Conditions
Breast Cancer
First Posted Date
2003-01-27
Last Posted Date
2013-12-18
Lead Sponsor
International Collaborative Cancer Group
Registration Number
NCT00010140
Locations
🇬🇧

Charing Cross Hospital, London, England, United Kingdom

Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer

Phase 1
Completed
Conditions
Head and Neck Cancer
Interventions
Procedure: Surgery
Radiation: radiation therapy
First Posted Date
2003-01-27
Last Posted Date
2017-06-16
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
31
Registration Number
NCT00006107
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Combination Chemotherapy Followed by Surgery in Treating Patients With Localized Prostate Cancer

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2003-01-27
Last Posted Date
2017-04-28
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
57
Registration Number
NCT00017563
Locations
🇺🇸

OHSU Knight Cancer Institute, Portland, Oregon, United States

🇺🇸

Portland VA Medical Center, Portland, Oregon, United States

Docetaxel in Treating Patients With Persistent or Recurrent Cervical Cancer

Phase 2
Completed
Conditions
Cervical Squamous Cell Carcinoma, Not Otherwise Specified
Recurrent Cervical Carcinoma
Interventions
First Posted Date
2003-01-27
Last Posted Date
2018-01-10
Lead Sponsor
Gynecologic Oncology Group
Target Recruit Count
27
Registration Number
NCT00041093
Locations
🇺🇸

Gynecologic Oncology Group, Philadelphia, Pennsylvania, United States

Docetaxel and Trastuzumab With or Without Carboplatin in Treating Women With HER2-Positive Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
Interventions
Biological: trastuzumab
Biological: trastuxumab
First Posted Date
2003-01-27
Last Posted Date
2020-08-03
Lead Sponsor
Jonsson Comprehensive Cancer Center
Target Recruit Count
263
Registration Number
NCT00047255
Locations
🇺🇸

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States

Safety/Efficacy Study of Immunoconjugate With Docetaxel in Non-small Cell Lung Carcinoma

Phase 2
Completed
Conditions
Carcinoma, Non-Small-Cell Lung
First Posted Date
2003-01-15
Last Posted Date
2011-10-24
Lead Sponsor
Seagen Inc.
Target Recruit Count
60
Registration Number
NCT00051571
Locations
🇺🇸

University of Chicago, Chicago, Illinois, United States

🇺🇸

Florida Cancer Specialists, Fort Myers, Florida, United States

🇺🇸

Virginia Mason Research Center, Seattle, Washington, United States

and more 6 locations

Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer

Phase 1
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2002-11-27
Last Posted Date
2011-08-29
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
603
Registration Number
NCT00050167
Locations
🇺🇸

UT MD Anderson Cancer Center, Houston, Texas, United States

Iressa/Docetaxel in Non-Small-Cell Lung Cancer

Phase 2
Withdrawn
Conditions
Non-small Cell Lung Cancer
Interventions
First Posted Date
2002-10-25
Last Posted Date
2012-07-31
Lead Sponsor
M.D. Anderson Cancer Center
Registration Number
NCT00048087
Locations
🇺🇸

UT MD Anderson Cancer Center, Houston, Texas, United States

This Study is to Assess the Efficacy and Safety of ZD6474 in Subjects With Non-small Cell Lung Cancer.

Phase 2
Completed
Conditions
Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-line
First Posted Date
2002-10-24
Last Posted Date
2016-08-25
Lead Sponsor
Genzyme, a Sanofi Company
Target Recruit Count
129
Registration Number
NCT00047840
Locations
🇭🇺

Research Site, Torokbalint, Hungary

ASCENT: Androgen Independent Prostate Cancer Study of Calcitriol Enhancing Taxotere

Phase 2
Conditions
Prostate Cancer
First Posted Date
2002-08-13
Last Posted Date
2009-03-12
Lead Sponsor
Novacea
Target Recruit Count
250
Registration Number
NCT00043576
Locations
🇺🇸

Tower Hematology Oncology Medical Group, Los Angeles, California, United States

🇺🇸

Texas Oncology, P.A., Dallas, Texas, United States

🇺🇸

Kaiser- Northern California, Vallejo, California, United States

and more 59 locations
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