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
-

Androgen Suppression and Radiation With/Out Docetaxel in High-Risk Localized Prostate Cancer

Phase 3
Terminated
Conditions
Prostate Cancer
Interventions
Drug: bicalutamide
Drug: buserelin
Drug: flutamide
Drug: goserelin
Drug: leuprolide acetate
Procedure: neoadjuvant therapy
Procedure: quality-of-life assessment
Radiation: radiation therapy
Drug: Docetaxel
First Posted Date
2008-04-02
Last Posted Date
2023-08-04
Lead Sponsor
NCIC Clinical Trials Group
Target Recruit Count
48
Registration Number
NCT00651326
Locations
🇨🇦

McGill University - Dept. Oncology, Montreal, Canada

🇨🇦

Tom Baker Cancer Centre, Calgary, Canada

🇨🇦

Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Canada

and more 10 locations

Epirubicin, Docetaxel, and Capecitabine in Treating Women With Stage IIIA or Stage IIIB Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
First Posted Date
2008-03-28
Last Posted Date
2011-05-16
Lead Sponsor
Mayo Clinic
Target Recruit Count
47
Registration Number
NCT00645866

Cetuximab, Combination Chemotherapy, and Radiation Therapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Head and Neck Cancer That Cannot Be Removed By Surgery

Phase 2
Terminated
Conditions
Head and Neck Cancer
First Posted Date
2008-03-28
Last Posted Date
2018-07-09
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Target Recruit Count
47
Registration Number
NCT00646659
Locations
🇧🇪

Universitair Ziekenhuis Antwerpen, Edegem, Belgium

A Study of an Experimental Chemotherapy Combination to Treat Hormone Refractory Prostate Cancer

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2008-03-24
Last Posted Date
2019-04-03
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
154
Registration Number
NCT00642018
Locations
🇪🇸

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Pamplona, Spain

Paricalcitol and Chemotherapy in Treating Women With Metastatic Breast Cancer

First Posted Date
2008-03-18
Last Posted Date
2017-05-30
Lead Sponsor
Wake Forest University Health Sciences
Target Recruit Count
24
Registration Number
NCT00637897
Locations
🇺🇸

Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States

Tarceva Italian Lung Optimization tRial

Phase 3
Conditions
Non Small Cell Lung Cancer (NSCLC)
Interventions
First Posted Date
2008-03-18
Last Posted Date
2012-02-24
Lead Sponsor
Fatebenefratelli and Ophthalmic Hospital
Target Recruit Count
850
Registration Number
NCT00637910
Locations
🇮🇹

D. Cotugno Hospital, Napoli, Italy

🇮🇹

Ospedale di Circolo, Varese, Italy

🇮🇹

Belcolle Hospital, Viterbo, Italy

and more 100 locations

Phase 1/2 Study of Vascular Disrupting Agent NPI-2358 + Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer

Phase 1
Completed
Conditions
Cancer
Interventions
First Posted Date
2008-03-06
Last Posted Date
2011-08-16
Lead Sponsor
Nereus Pharmaceuticals, Inc.
Target Recruit Count
172
Registration Number
NCT00630110
Locations
🇦🇷

Hospital Britanico, Capital Federal, Argentina

🇺🇸

Mayo Clinic, Scottsdale, Arizona, United States

🇦🇺

Mater Adult Hospital, South Brisbane, Queensland, Australia

and more 33 locations

Safety and Efficacy Comparison of Docetaxel and Ixabepilone in Non Metastatic Poor Prognosis Breast Cancer

First Posted Date
2008-03-06
Last Posted Date
2024-02-21
Lead Sponsor
UNICANCER
Target Recruit Count
762
Registration Number
NCT00630032
Locations
🇧🇪

Institut Jules Bordet, Brussels, Belgium

🇫🇷

Centre Hospitalier Docteur Duchenne, Boulogne Sur Mer, France

🇺🇸

CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, United States

and more 82 locations

Combination Chemotherapy and Trastuzumab in Treating Women With Stage I, Stage II, or Stage III HER2-Positive Breast Cancer

Phase 3
Conditions
Breast Cancer
First Posted Date
2008-03-05
Last Posted Date
2013-08-07
Lead Sponsor
Azienda Ospedaliero-Universitaria di Modena
Target Recruit Count
2500
Registration Number
NCT00629278
Locations
🇮🇹

Ospedal San Andrea, Vercelli, Italy

🇮🇹

Ospedale Civile di Ivrea, Ivrea, Italy

🇮🇹

Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino, Turin, Italy

and more 3 locations

BETH Study: Treatment of HER2 Positive Breast Cancer With Chemotherapy Plus Trastuzumab vs Chemotherapy Plus Trastuzumab Plus Bevacizumab

First Posted Date
2008-02-29
Last Posted Date
2020-09-10
Lead Sponsor
NSABP Foundation Inc
Target Recruit Count
3509
Registration Number
NCT00625898
Locations
🇺🇸

Peninsula Regional Oncology & Hematology, Salisbury, Maryland, United States

🇺🇸

Associates in Oncology/Hematology, Rockville, Maryland, United States

🇺🇸

The Office of Frederik Smith, Chevy Chase, Maryland, United States

and more 636 locations
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