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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
-

TaxXel: Taxotere and Xeloda in Esophageal Cancer

Phase 1
Conditions
Cancer of the Esophagus
Gastric Cardia Carcinoma
Interventions
First Posted Date
2009-01-14
Last Posted Date
2012-02-28
Lead Sponsor
Karolinska University Hospital
Target Recruit Count
93
Registration Number
NCT00821912
Locations
🇳🇴

Haukeland universitetssykehus, Bergen, Norway

🇸🇪

Malmö General University Hospital, Malmö, Sweden

🇸🇪

Västerås Central Hospital, Västerås, Sweden

and more 7 locations

Docetaxel, Carboplatin, Trastuzumab, and Lapatinib in Treating Patients With Early Stage Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2009-01-12
Last Posted Date
2019-10-21
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
30
Registration Number
NCT00820872
Locations
🇺🇸

Cancer Center of Kansas-Independence, Independence, Kansas, United States

🇺🇸

Bismarck Cancer Center, Bismarck, North Dakota, United States

🇺🇸

Kalispell Regional Medical Center, Kalispell, Montana, United States

and more 130 locations

Efficacy and Tolerance Study of Bevacizumab in Her2- Inflammatory Breast Cancer Patients

Phase 2
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2009-01-12
Last Posted Date
2019-10-22
Lead Sponsor
UNICANCER
Target Recruit Count
100
Registration Number
NCT00820547
Locations
🇫🇷

Centre Paul Papin, Angers, France

🇫🇷

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz, Besancon, France

🇫🇷

Institut Sainte Catherine, Avignon, France

and more 25 locations

Trial of Weekly Taxotere and Irinotecan (CPT-11) in Patients With Advanced Non-small Cell Lung Cancer

Phase 2
Completed
Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
First Posted Date
2009-01-09
Last Posted Date
2011-01-11
Lead Sponsor
Sanofi
Target Recruit Count
35
Registration Number
NCT00819728
Locations
🇺🇸

Sanofi-Aventis US, Bridgewater, New Jersey, United States

Docetaxel + Oxaliplatin + S-1 in Potentially Operable Gastric or Gastroesophageal Adenocarcinoma

Phase 2
Completed
Conditions
Gastric Cancer
Interventions
First Posted Date
2009-01-01
Last Posted Date
2012-12-18
Lead Sponsor
Sanofi
Target Recruit Count
41
Registration Number
NCT00816543
Locations
🇰🇷

Sanofi-Aventis Administrative Office, Seoul, Korea, Republic of

Study of PEP02, Irinotecan or Docetaxel in Gastric or Gastroesophageal Junction Adenocarcinoma

Phase 2
Completed
Conditions
Stomach Neoplasms
Esophageal Neoplasms
Interventions
First Posted Date
2008-12-22
Last Posted Date
2012-03-02
Lead Sponsor
PharmaEngine
Target Recruit Count
135
Registration Number
NCT00813072
Locations
🇪🇸

Hospital Universitario Vall d'Hebron, Barcelona, Spain

🇪🇸

Hospital Clínico San Carlos, Madrid, Spain

🇪🇸

Hospital Universitario Marques de Valdecilla, Santander, Spain

and more 19 locations

Taxotere New Indication - Gastric Cancer Treatment Registration Trial

Phase 3
Completed
Conditions
Stomach Neoplasms
Interventions
First Posted Date
2008-12-19
Last Posted Date
2012-08-31
Lead Sponsor
Sanofi
Target Recruit Count
243
Registration Number
NCT00811447
Locations
🇨🇳

Sanofi-Aventis Administrative Office, Shanghai, China

A Study to Determine the Maximum Tolerated Dose of Elesclomol Sodium Given With a Fixed Dose of Docetaxel and Prednisone in Patients With Metastatic Prostate Cancer

Phase 1
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2008-12-15
Last Posted Date
2014-02-03
Lead Sponsor
Synta Pharmaceuticals Corp.
Target Recruit Count
34
Registration Number
NCT00808418
Locations
🇺🇸

Mayo Clinic, Rochester, Maryland, United States

🇺🇸

Pacific Coast Hematology/Oncology Medical Group, Fountain Valley, California, United States

🇺🇸

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin, United States

and more 2 locations

Cyclophosphamide and Docetaxel or Doxorubicin in Treating Women With Newly Diagnosed Breast Cancer That Can Be Removed by Surgery

First Posted Date
2008-12-03
Last Posted Date
2009-06-17
Lead Sponsor
National Cancer Centre, Singapore
Target Recruit Count
318
Registration Number
NCT00801411
Locations
🇸🇬

National Cancer Centre - Singapore, Singapore, Singapore

🇸🇬

Singapore General Hospital, Singapore, Singapore

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