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
-

Docetaxel, Oxaliplatin, Capecitabine, Fluorouracil, and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction

Phase 2
Completed
Conditions
Adenocarcinoma of the Gastroesophageal Junction
Esophageal Cancer
Gastric Cancer
Interventions
Drug: fluorouracil
Drug: capecitabine
Drug: docetaxel
Drug: oxaliplatin
Radiation: radiation therapy
Procedure: therapeutic conventional surgery
First Posted Date
2009-07-13
Last Posted Date
2018-03-29
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
73
Registration Number
NCT00938470
Locations
🇺🇸

Graham Hospital, Canton, Illinois, United States

🇺🇸

Illinois CancerCare - Galesburg, Galesburg, Illinois, United States

🇺🇸

Mason District Hospital, Havana, Illinois, United States

and more 182 locations

S0716 Vandetanib and Docetaxel in Treating Patients With Advanced Solid Tumors

Phase 1
Withdrawn
Conditions
Breast Cancer
Head and Neck Cancer
Prostate Cancer
Lung Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
Drug: docetaxel
Drug: vandetanib
Genetic: proteomic profiling
Other: laboratory biomarker analysis
Other: pharmacological study
First Posted Date
2009-07-13
Last Posted Date
2017-04-24
Lead Sponsor
SWOG Cancer Research Network
Registration Number
NCT00937417

High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors

Phase 2
Completed
Conditions
Testicular Cancer
Interventions
First Posted Date
2009-07-10
Last Posted Date
2024-08-26
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
64
Registration Number
NCT00936936
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

🇺🇸

Fred Hutchinson Cancer Center, Seattle, Washington, United States

A Study of Trastuzumab Emtansine (T-DM1) in Combination With Docetaxel, and Potentially Pertuzumab, in Participants With Advanced Breast Cancer

Phase 1
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2009-07-08
Last Posted Date
2017-04-06
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
98
Registration Number
NCT00934856

Assessment of the Efficacy of the Neoadjuvant Combination: "Chemotherapy-Targeted Therapy" in Breast Cancer.

Phase 2
Completed
Conditions
Pathological Response Rate
First Posted Date
2009-07-07
Last Posted Date
2014-03-21
Lead Sponsor
Centre Jean Perrin
Target Recruit Count
62
Registration Number
NCT00933517
Locations
🇫🇷

Centre Léon Bérard, Lyon, France

🇫🇷

Centre Jean Perrin, Clermont-Ferrand, France

🇫🇷

Institut de Cancérologie de la Loire, Saint Priest en Jarez, France

and more 9 locations

An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

Phase 3
Completed
Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
First Posted Date
2009-07-03
Last Posted Date
2017-01-02
Lead Sponsor
Pfizer
Target Recruit Count
347
Registration Number
NCT00932893
Locations
🇺🇸

UCLA Hematology Oncology, Los Angeles, California, United States

🇺🇸

The Ohio State University Hospital East, Columbus, Ohio, United States

🇺🇸

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States

and more 241 locations

Docetaxel/Prednisone Plus Fractionated 177Lu- J591 Antibody for Metastatic, Castrate-resistant Prostate Cancer

Phase 1
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2009-06-09
Last Posted Date
2021-05-20
Lead Sponsor
Weill Medical College of Cornell University
Target Recruit Count
15
Registration Number
NCT00916123
Locations
🇺🇸

Weill Cornell Medical College, New York, New York, United States

🇺🇸

University of North Carolina Chapel Hill Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States

TC Avastin. ICORG 08-10, V6

Not Applicable
Completed
Conditions
Breast Cancer
Interventions
Biological: bevacizumab
Drug: cyclophosphamide
Drug: docetaxel
Procedure: adjuvant therapy
First Posted Date
2009-06-02
Last Posted Date
2019-08-01
Lead Sponsor
Cancer Trials Ireland
Target Recruit Count
106
Registration Number
NCT00911716
Locations
🇮🇪

Cancer Trials Ireland Investigative Site, Waterford, Ireland

🇩🇰

Dept. of Oncology; Rigshospitalet, Blegdamsvej, Copenhagen, Denmark

Phase 2 Sequential and Concurrent Chemoradiation for Advanced Nasopharyngeal Carcinoma (NPC)

Phase 2
Completed
Conditions
Stage II Lymphoepithelioma of the Nasopharynx
Stage III Lymphoepithelioma of the Nasopharynx
Stage III Squamous Cell Carcinoma of the Nasopharynx
Stage IV Lymphoepithelioma of the Nasopharynx
Stage IV Squamous Cell Carcinoma of the Nasopharynx
Stage II Squamous Cell Carcinoma of the Nasopharynx
Interventions
Drug: docetaxel
Drug: cisplatin
Drug: carboplatin
Drug: fluorouracil
Radiation: 3-dimensional conformal radiation therapy
Radiation: intensity-modulated radiation therapy
First Posted Date
2009-05-11
Last Posted Date
2021-04-06
Lead Sponsor
Stanford University
Target Recruit Count
26
Registration Number
NCT00896181
Locations
🇺🇸

Stanford University Hospitals and Clinics, Stanford, California, United States

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