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
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A Study of Mycobacterium w Plus Docetaxel for Hormone Refractory Metastatic Prostate Cancer

Phase 2
Terminated
Conditions
Hormone Refractory Prostate Cancer
Interventions
Biological: Mycobacterium w.
Drug: Docetaxel
First Posted Date
2007-09-05
Last Posted Date
2012-03-12
Lead Sponsor
Cadila Pharnmaceuticals
Target Recruit Count
134
Registration Number
NCT00525408
Locations
🇮🇳

Regional Cancer Centre, Trivandrum, Kerala, India

🇮🇳

Post Graduate Institute of Medical Education and Research, Chandigarh, India

🇮🇳

V.M. Medical College & Safdarjang Hospital, New Delhi, Delhi, India

and more 11 locations

p53-Adjusted Neoadjuvant Chemotherapy for Potentially Resectable Esophageal Cancer

Phase 3
Completed
Conditions
Esophageal Cancer
Interventions
Drug: 5-Fluoruracil, Cisplatinum
Drug: Docetaxel
First Posted Date
2007-09-05
Last Posted Date
2012-12-21
Lead Sponsor
Daniela Kandioler
Target Recruit Count
170
Registration Number
NCT00525200
Locations
🇦🇹

SMZ OST, Vienna, Austria

🇦🇹

Landesklinikum Wiener Neustadt, Wiener Neustadt, Lower Austria, Austria

🇦🇹

Landesklinikum St. Pölten, St. Polten, Lower Austria, Austria

and more 10 locations

Liposomal Doxorubicin and Docetaxel in Metastatic Breast Cancer

Phase 2
Completed
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2007-09-05
Last Posted Date
2011-06-30
Lead Sponsor
ARCAGY/ GINECO GROUP
Target Recruit Count
67
Registration Number
NCT00524810
Locations
🇫🇷

Hôpital HOTEL DIEU, Paris, France

Pegylated Liposomal Doxorubicin and Docetaxel in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery

Phase 2
Terminated
Conditions
Breast Cancer
First Posted Date
2007-09-03
Last Posted Date
2014-08-29
Lead Sponsor
Roswell Park Cancer Institute
Target Recruit Count
6
Registration Number
NCT00524459
Locations
🇺🇸

Roswell Park Cancer Institute, Buffalo, New York, United States

Study of Combination Docetaxel and Radiotherapy With or Without Cisplatin to Treat Local Advanced Head and Neck Cancer

Phase 2
Completed
Conditions
Head and Neck Neoplasms
Interventions
First Posted Date
2007-08-28
Last Posted Date
2009-12-07
Lead Sponsor
Sanofi
Target Recruit Count
86
Registration Number
NCT00521521
Locations
🇫🇷

Sanofi-Aventis, Paris, France

Celecoxib and Docetaxel or Pemetrexed in Treating Patients With Advanced Recurrent Non-Small Cell Lung Cancer

Phase 2
Terminated
Conditions
Lung Cancer
Interventions
First Posted Date
2007-08-27
Last Posted Date
2017-03-20
Lead Sponsor
Vanderbilt-Ingram Cancer Center
Target Recruit Count
23
Registration Number
NCT00520845
Locations
🇺🇸

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

🇺🇸

Vanderbilt-Ingram Cancer Center - Cool Springs, Nashville, Tennessee, United States

🇺🇸

Vanderbilt-Ingram Cancer Center at Franklin, Nashville, Tennessee, United States

Study of Trovax® Plus Docetaxel Versus Docetaxel Alone in Patients With Progressive Hormone Refractory Prostate Cancer

Phase 2
Terminated
Conditions
Prostatic Neoplasms
Interventions
Biological: MVA 5T4
Drug: Docetaxel
First Posted Date
2007-08-27
Last Posted Date
2016-03-17
Lead Sponsor
The Methodist Hospital Research Institute
Target Recruit Count
11
Registration Number
NCT00521274
Locations
🇺🇸

Baylor College of Medicine - Methodist Hospital, Houston, Texas, United States

Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer

Phase 3
Completed
Conditions
Non-Small Cell Lung Cancer
Interventions
First Posted Date
2007-08-24
Last Posted Date
2011-08-10
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
260
Registration Number
NCT00520676
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., Tao-Yuan, Taiwan

Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer

Phase 3
Completed
Conditions
Neoplasm Metastasis
Prostatic Neoplasms
Interventions
First Posted Date
2007-08-22
Last Posted Date
2016-07-22
Lead Sponsor
Sanofi
Target Recruit Count
1224
Registration Number
NCT00519285
Locations
🇬🇧

Sanofi-Aventis Administrative Office, Guildford Surrey, United Kingdom

Docetaxel+Oxali+/-Cetux Met Gastric/GEJ

Phase 2
Completed
Conditions
Gastric Cancer Adenocarcinoma Metastatic
Interventions
First Posted Date
2007-08-17
Last Posted Date
2016-11-28
Lead Sponsor
US Oncology Research
Target Recruit Count
150
Registration Number
NCT00517829
Locations
🇺🇸

Central Indiana Cancer Centers, Indianapolis, Indiana, United States

🇺🇸

Minnesota Oncology Hematology, P.A., Minneapolis, Minnesota, United States

🇺🇸

Birmingham Hematology and Oncology, Birmingham, Alabama, United States

and more 40 locations
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