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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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Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy

Phase 2
Active, not recruiting
Conditions
Prostate Cancer
Interventions
First Posted Date
2005-12-22
Last Posted Date
2023-04-18
Lead Sponsor
Medical Research Council
Target Recruit Count
11992
Registration Number
NCT00268476
Locations
🇬🇧

West Suffolk Hospital, Bury St. Edmunds, England, United Kingdom

🇬🇧

Derbyshire Royal Infirmary, Derby, England, United Kingdom

🇬🇧

Russells Hall Hospital, Dudley, England, United Kingdom

and more 115 locations

Docetaxel in Hormone Refractory Prostate Cancer (HRPC)[Weekly or 3weekly TAX + Prednisone in HRPC]

Phase 2
Completed
Conditions
Prostatic Neoplasms
First Posted Date
2005-12-22
Last Posted Date
2009-12-07
Lead Sponsor
Sanofi
Registration Number
NCT00268710

Docetaxel in Squamous Cell Carcinoma of the Head and Neck (TAX + Cisplatin in SCCHN)

Phase 1
Completed
Conditions
Head and Neck Neoplasms
First Posted Date
2005-12-22
Last Posted Date
2009-12-07
Lead Sponsor
Sanofi
Target Recruit Count
45
Registration Number
NCT00268671

Docetaxel, Irinotecan, and Carboplatin in Extensive Stage Non-Small Cell Lung Cancer

Phase 1
Terminated
Conditions
Non-small Cell Lung Cancer
Extensive Stage Unresectable
First Posted Date
2005-12-12
Last Posted Date
2010-01-20
Lead Sponsor
Kentuckiana Cancer Institute
Target Recruit Count
40
Registration Number
NCT00264134
Locations
🇺🇸

Kentuckiana Cancer Institute, Louisville, Kentucky, United States

Docetaxel in Non Small Cell Lung Cancer (NSCLC)

Phase 2
Terminated
Conditions
Carcinoma, Non-Small-Cell Lung
First Posted Date
2005-12-07
Last Posted Date
2008-03-20
Lead Sponsor
Sanofi
Target Recruit Count
50
Registration Number
NCT00263016
Locations
🇭🇰

Sanofi-aventis, Hong Kong, Hong Kong

Safety and Pharmacokinetics of Jin Fu Kang in Comb w/Docetaxel for Patients w/Non-Small Cell Lung Cancer

Phase 2
Completed
Conditions
Non-Small Cell Lung Cancer
First Posted Date
2005-12-01
Last Posted Date
2007-01-26
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
20
Registration Number
NCT00260026
Locations
🇺🇸

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Adjuvant Docetaxel-Zoledronic Acid in High-risk Early Prostate Cancer Following Prostatectomy.

Phase 2
Terminated
Conditions
Prostate Cancer
Interventions
First Posted Date
2005-11-28
Last Posted Date
2010-04-26
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
1
Registration Number
NCT00258765
Locations
🇦🇺

Novartis Investigative Site, Sydney, Australia

Docetaxel and Prednisone With/Out OGX-011 in Recurrent or Metastatic Prostate Cancer That Did Not Respond to Previous Hormone Therapy

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2005-11-24
Last Posted Date
2023-08-04
Lead Sponsor
NCIC Clinical Trials Group
Target Recruit Count
82
Registration Number
NCT00258388
Locations
🇨🇦

London Regional Cancer Program, London, Canada

🇨🇦

BCCA - Cancer Centre for the Southern Interior, Kelowna, Canada

🇺🇸

University of Washington, Seattle, Washington, United States

and more 10 locations

Capecitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2005-11-24
Last Posted Date
2014-03-06
Lead Sponsor
Barbara Ann Karmanos Cancer Institute
Target Recruit Count
30
Registration Number
NCT00258284
Locations
🇺🇸

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

Carboplatin, Docetaxel, and Radiation Therapy in Treating Patients With Stage III/IV, or Recurrent Endometrial Cancer

Phase 2
Completed
Conditions
Endometrial Cancer
Interventions
Drug: carboplatin
Drug: docetaxel
Radiation: radiation therapy
First Posted Date
2005-11-24
Last Posted Date
2017-12-28
Lead Sponsor
Masonic Cancer Center, University of Minnesota
Target Recruit Count
41
Registration Number
NCT00258362
Locations
🇺🇸

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

🇺🇸

Park Nicollet Cancer Center, Saint Louis Park, Minnesota, United States

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