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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A Phase II Study of Capecitabine and Docetaxel in Previously Untreated Advanced Non-Small Cell Lung Cancer Patients

First Posted Date
2005-09-20
Last Posted Date
2014-10-06
Lead Sponsor
Tony Bekaii-Saab
Target Recruit Count
29
Registration Number
NCT00201825
Locations
🇺🇸

Ohio State University, Columbus, Ohio, United States

Phase I & Biological Study of Etanercept & Weekly Docetaxel in Patients With Advanced Solid Tumors

Phase 1
Completed
Conditions
First Posted Date
2005-09-20
Last Posted Date
2017-12-06
Lead Sponsor
Ohio State University Comprehensive Cancer Center
Target Recruit Count
27
Registration Number
NCT00201812
Locations
🇺🇸

Ohio State University Medical Center, Columbus, Ohio, United States

Randomized Phase 2 Study of 3 Therapeutic Modalities in PS 2/3 Patients With NSCLC Stage IIIB/IV

First Posted Date
2005-09-20
Last Posted Date
2010-04-30
Lead Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Target Recruit Count
126
Registration Number
NCT00198393
Locations
🇫🇷

CHU Grenoble - pneumologie, Grenoble, France

🇫🇷

CHU Avicenne - Oncologie, Bobigny, France

Docetaxel, Vinorelbine and Trastuzumab in the Treatment of Patients With Metastatic Her-2 Positive Breast Cancer

Phase 2
Completed
Conditions
First Posted Date
2005-09-19
Last Posted Date
2015-12-10
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
60
Registration Number
NCT00193089

Chemotherapy Plus Gefitinib Followed by Chemotherapy, Radiation Therapy, and Gefitinib For Head and Neck Cancer

Phase 2
Completed
Conditions
First Posted Date
2005-09-19
Last Posted Date
2010-06-22
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
50
Registration Number
NCT00193284
Locations
🇺🇸

Tennessee Oncology, PLLC, Nashville, Tennessee, United States

Topotecan in Combination With Docetaxel in Refractory and/or Advanced Solid Tumors

Phase 1
Completed
Conditions
First Posted Date
2005-09-19
Last Posted Date
2009-01-23
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
20
Registration Number
NCT00193570

Phase III Study of Gemcitabine Plus a Cytotoxic Agent Versus Two Cytotoxic Agents

Phase 3
Completed
Conditions
First Posted Date
2005-09-19
Last Posted Date
2007-05-28
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
300
Registration Number
NCT00191438
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 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Nottingham City, Nottinghamshire, United Kingdom

A Trial Of Gemcitabine Plus Paclitaxel And Gemcitabine Plus Docetaxel In Metastatic Breast Cancer

Phase 2
Completed
Conditions
First Posted Date
2005-09-19
Last Posted Date
2007-01-26
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
120
Registration Number
NCT00191672
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 - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Katy, Texas, United States

🇺🇸

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

A Randomized Study Evaluating the Feasibility and Activity of Three Different Combination With Gemcitabine as First Line Therapy for Non Small Cell Lung Cancer

Phase 2
Completed
Conditions
First Posted Date
2005-09-19
Last Posted Date
2007-01-26
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
162
Registration Number
NCT00191490
Locations
🇮🇹

For additional information regarding investigative sites for this trial, please call 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Monday-Friday, 9:00 am to 5:00 pm Eastern time (UTC/GMT - 5 hours, EST) or speak with your physician, Sesto Fiorentino, Florence, Italy

Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced Non-Small Cell Lung Cancer

Phase 2
Completed
Conditions
Interventions
First Posted Date
2005-09-19
Last Posted Date
2012-11-13
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
69
Registration Number
NCT00193453
Locations
🇺🇸

Gainsville Hematology Oncology Associates, Gainesville, Florida, United States

🇺🇸

Florida Cancer Specialists, Fort Myers, Florida, United States

🇺🇸

Northeast Arkansas Clinic, Jonesboro, Arkansas, United States

and more 7 locations
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