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
-

Combination Weekly Taxotere™ With Iressa™ /Placebo in Metastatic Breast Cancer

Phase 2
Completed
Conditions
Metastatic Breast Cancer
First Posted Date
2006-04-27
Last Posted Date
2007-12-18
Lead Sponsor
AstraZeneca
Target Recruit Count
66
Registration Number
NCT00319618
Locations
🇳🇴

Research Site, Oslo, Norway

Sequential vs Upfront Intensified Neoadjuvant Chemotherapy in Patients With Large Resectable or Locally Advanced Breast Cancer.

Phase 3
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2006-04-17
Last Posted Date
2010-03-18
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
200
Registration Number
NCT00314977
Locations
🇳🇱

Jeroen Bosch Ziekenhuis, Den Bosch, Netherlands

🇳🇱

Deventer Ziekenhuis, Deventer, Netherlands

🇳🇱

Catharina Ziekenhuis, Eindhoven, Netherlands

and more 21 locations

Phase I Study of ZD4054 (Zibotentan) and Docetaxel in Patients With Metastatic HRPC

Phase 1
Completed
Conditions
Prostate Cancer
Interventions
Drug: ZD4054 (Zibotentan)
Drug: Docetaxel
Drug: Placebo
First Posted Date
2006-04-17
Last Posted Date
2013-03-12
Lead Sponsor
AstraZeneca
Target Recruit Count
44
Registration Number
NCT00314782
Locations
🇬🇧

Research Site, Surrey, United Kingdom

PII Trial of Docetaxel/Prednisone w/Sargramostim for HRPC

Phase 2
Terminated
Conditions
Hormone Refractory Prostate Cancer
First Posted Date
2006-04-12
Last Posted Date
2012-05-11
Lead Sponsor
Veeda Oncology
Target Recruit Count
35
Registration Number
NCT00313482
Locations
🇺🇸

Veeda Oncology, Columbus, Ohio, United States

Study of CP-751,871 in Combination With Docetaxel and Prednisone in Patients With Hormone Insensitive Prostate Cancer (HRPC)

Phase 2
Completed
Conditions
Prostatic Neoplasms
Interventions
First Posted Date
2006-04-12
Last Posted Date
2013-04-11
Lead Sponsor
Pfizer
Target Recruit Count
204
Registration Number
NCT00313781
Locations
🇬🇧

Pfizer Investigational Site, Guildford, United Kingdom

ZACTIMA (an Anti-EGFR / Anti-VEGF Agent) Combined With Docetaxel Compared to Docetaxel in Non-small Cell Lung Cancer

Phase 3
Completed
Conditions
Lung Cancer
Non-small Cell Lung Cancer
Interventions
First Posted Date
2006-04-10
Last Posted Date
2016-09-30
Lead Sponsor
Genzyme, a Sanofi Company
Target Recruit Count
1690
Registration Number
NCT00312377
Locations
🇻🇳

Research Site, Ho Chi Minh city, Vietnam

Triptorelin in Preventing Early Menopause in Premenopausal Women Who Are Receiving Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer That Has Been Removed By Surgery

Phase 3
Completed
Conditions
Breast Cancer
First Posted Date
2006-04-06
Last Posted Date
2013-06-26
Lead Sponsor
Gruppo Italiano Mammella (GIM)
Target Recruit Count
280
Registration Number
NCT00311636
Locations
🇮🇹

Ospedale Civile, Castelfranco - TV, Italy

🇮🇹

Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

🇮🇹

Ospedale Sant Anna, Como, Italy

and more 15 locations

Randomized Neoadjuvant Study of Epirubicin and Docetaxel With/Without Capecitabine in Early Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2006-04-03
Last Posted Date
2011-12-30
Lead Sponsor
Austrian Breast & Colorectal Cancer Study Group
Target Recruit Count
536
Registration Number
NCT00309556
Locations
🇦🇹

Hospital BHB St. Veit/Glan, Surgery, St. Veit a. d. Glan, Carinthia, Austria

🇦🇹

State Hospital Klagenfurt, Klagenfurt, Carinthia, Austria

🇦🇹

Hospital Guessing, Guessing, Burgenland, Austria

and more 23 locations

AZD2171 and Combination Chemotherapy in Treating Women With Locally Advanced Breast Cancer

Not Applicable
Completed
Conditions
Breast Cancer
First Posted Date
2006-04-03
Last Posted Date
2013-06-20
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
33
Registration Number
NCT00310089
Locations
🇺🇸

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland, United States

🇺🇸

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States

Combination Chemotherapy With or Without Darbepoetin Alfa in Treating Women With Stage III Breast Cancer

Not Applicable
Conditions
Breast Cancer
First Posted Date
2006-04-03
Last Posted Date
2009-02-09
Lead Sponsor
Heinrich-Heine University, Duesseldorf
Target Recruit Count
1234
Registration Number
NCT00309920
Locations
🇩🇪

Knappschaft Krankenhaus, Bochum-Langendreer, Germany

🇩🇪

Praxis Fuer Haematologie Internistische Onkologie, Cologne, Germany

🇩🇪

St. Elisabeth-Krankenhaus - Koeln, Cologne, Germany

and more 44 locations
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