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
-

Ascending Multiple-Dose Study of Brivanib Alaninate in Combination With Chemotherapeutic Agents in Subjects With Advanced Cancers

First Posted Date
2008-11-26
Last Posted Date
2015-07-07
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
111
Registration Number
NCT00798252
Locations
🇨🇦

Local Institution, Toronto, Ontario, Canada

🇺🇸

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

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

and more 1 locations

Androgen Ablation With or Without Docetaxel in Treating Patients With Advanced Prostate Cancer

Phase 3
Conditions
Pain
Prostate Cancer
Interventions
Drug: releasing hormone agonist therapy
Drug: docetaxel
First Posted Date
2008-11-24
Last Posted Date
2013-08-12
Lead Sponsor
A.O.U. San Giovanni Battista di Torino, Italy
Target Recruit Count
200
Registration Number
NCT00796458
Locations
🇮🇹

Rete Oncologica Piemontese - Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino, Turin, Italy

Biomarker Study for Sunitinib and Docetaxel in Prostate Cancer

Phase 2
Conditions
Hormone Refractory Prostate Cancer
Interventions
First Posted Date
2008-11-21
Last Posted Date
2010-08-18
Lead Sponsor
Medical University of Vienna
Target Recruit Count
60
Registration Number
NCT00795171
Locations
🇦🇹

Dept of Internal Medicine, Vienna, Austria

Docetaxel and Hydroxychloroquine in Treating Patients With Metastatic Prostate Cancer

Phase 2
Terminated
Conditions
Prostate Cancer
Interventions
First Posted Date
2008-11-06
Last Posted Date
2023-08-14
Lead Sponsor
University of Medicine and Dentistry of New Jersey
Target Recruit Count
11
Registration Number
NCT00786682
Locations
🇺🇸

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

🇺🇸

Cancer Institute of New Jersey at Hamilton, Hamilton, New Jersey, United States

🇺🇸

Overlook Hospital, Summit, New Jersey, United States

and more 4 locations

A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies

First Posted Date
2008-10-29
Last Posted Date
2025-01-03
Lead Sponsor
Genentech, Inc.
Target Recruit Count
720
Registration Number
NCT00781612
Locations
🇺🇸

Can Care Assoc Med Group Inc, Redondo Beach, California, United States

🇺🇸

Univ of Calif, San Francisco, San Francisco, California, United States

🇺🇸

UCLA Oncology Office, Santa Monica, California, United States

and more 177 locations

PRIMADOS Study:A Study of Avastin (Bevacizumab) Plus Docetaxel for First Line Treatment of Patients With Metastatic Breast Cancer

Phase 4
Withdrawn
Conditions
Breast Cancer
Interventions
First Posted Date
2008-10-17
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Registration Number
NCT00774241

A Study of Bevacizumab (Avastin) in Combination With Neoadjuvant Treatment Regimens in Participants With Primary Human Epidermal Growth Factor Receptor 2 (HER2) Negative Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2008-10-16
Last Posted Date
2023-01-09
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
150
Registration Number
NCT00773695
Locations
🇳🇴

Ullevael Sykehus; Dept of Oncology, Oslo, Norway

🇳🇴

The Norvegian Radium Hospital Montebello; Dept of Oncology, Oslo, Norway

🇳🇴

St. Olavs Hospital; Kreftavdelingen, Trondheim, Norway

Docetaxel, Carboplatin, and Trastuzumab and/or Lapatinib in Treating Women With Stage I, Stage II, or Stage III Breast Cancer That Can Be Removed by Surgery

Phase 2
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2008-10-09
Last Posted Date
2016-01-22
Lead Sponsor
Translational Oncology Research International
Target Recruit Count
18
Registration Number
NCT00769470
Locations
🇺🇸

Comprehensive Blood and Cancer Center, Bakersfield, California, United States

🇺🇸

St. Jude Heritage Medical Group at Virginia K. Crosson Cancer Center, Fullerton, California, United States

🇺🇸

Sansum Medical Clinic, Santa Barbara, California, United States

and more 12 locations

Phase II Avastin Trial for Stage IIIB/IV NSCLC

Phase 2
Terminated
Conditions
Non-small Cell Lung Cancer Stage IIIB
Non-small Cell Lung Cancer Stage IV
Interventions
First Posted Date
2008-10-03
Last Posted Date
2016-04-19
Lead Sponsor
Pharmatech
Target Recruit Count
125
Registration Number
NCT00766246

A Prospective Randomized Phase III Study Comparing Hormonal Therapy +/-Docetaxel

Phase 3
Conditions
Adenocarcinoma of the Prostate
Interventions
Drug: Docetaxel + hormonal treatment (LH-RH agonist)
Drug: Hormonal treatment (LH-RH agonist)
First Posted Date
2008-10-01
Last Posted Date
2008-10-01
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
254
Registration Number
NCT00764166
Locations
🇫🇷

Service Oncologie Médicale, Hopital Europeen Georges Pompidou, Paris, France

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