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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
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Neoadjuvant Chemotherapy With Docetaxel and Gemcitabine in Locally Advanced Breast Cancer

Phase 2
Conditions
Breast Cancer Stage II
Breast Cancer Stage III
Interventions
First Posted Date
2011-05-12
Last Posted Date
2011-05-27
Lead Sponsor
Korean Breast Cancer Study Group
Target Recruit Count
99
Registration Number
NCT01352494
Locations
🇰🇷

Department of Surgery, the Catholic university of Korea, St. Vincent's hospital, Suwon, Gyeonggi-do, Korea, Republic of

A Study of Bevacizumab in Combination With Standard of Care Treatment in Participants With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)

Phase 3
Completed
Conditions
Non-Squamous Non-Small Cell Lung Cancer
Interventions
First Posted Date
2011-05-10
Last Posted Date
2017-09-18
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
485
Registration Number
NCT01351415
Locations
🇺🇸

University of Pennsylvania; Radiation Oncology, Philadelphia, Pennsylvania, United States

🇯🇵

Miyagi Cancer Center; Respiratory Medicine, Miyagi, Japan

🇺🇸

USA Mitchell Cancer Institute, Mobile, Alabama, United States

and more 176 locations

Erlotinib and Docetaxel in Second Line of Treatment in Patients With Non Small Cell Lung Cancer

Phase 2
Completed
Conditions
Non Small Cell Lung Cancer
Interventions
First Posted Date
2011-05-10
Last Posted Date
2015-04-03
Lead Sponsor
University Hospital, Limoges
Target Recruit Count
156
Registration Number
NCT01350817
Locations
🇫🇷

Service de pneumologie; Centre Hospitalier d'Annecy, Annecy, France

🇫🇷

Service de Pneumologie; Centre Hospitalier, Draguignan, France

🇫🇷

Service de Pneumologie; CHG de Roanne, Roanne, France

and more 17 locations

Study of Ganetespib (STA-9090) + Docetaxel in Advanced Non Small Cell Lung Cancer

Phase 2
Terminated
Conditions
Non-small Cell Lung Cancer Stage IIIB
Non-small Cell Lung Cancer Stage IV
Non-small Cell Lung Cancer Metastatic
Interventions
First Posted Date
2011-05-05
Last Posted Date
2015-11-05
Lead Sponsor
Synta Pharmaceuticals Corp.
Target Recruit Count
385
Registration Number
NCT01348126
Locations
🇬🇧

Synta Pharmaceuticals Investigative Site, London, United Kingdom

🇬🇧

Synta Pharmaceuticals Investigational Site, Sutton, United Kingdom

🇺🇸

Synta Pharmaceutials Investigative Site, Boston, Massachusetts, United States

and more 1 locations

Everolimus and Docetaxel in Treating Patients With Recurrent, Locally Advanced, or Metastatic Head and Neck Cancer

Phase 1
Terminated
Conditions
Head and Neck Cancer
First Posted Date
2011-03-11
Last Posted Date
2011-12-12
Lead Sponsor
University College, London
Target Recruit Count
4
Registration Number
NCT01313390
Locations
🇬🇧

UCL Cancer Institute, London, England, United Kingdom

A Study of Herceptin (Trastuzumab) in Combination With a Taxane in Participants With HER2-Positive Breast Cancer Who Relapsed After (Neo)Adjuvant Herceptin Treatment

Phase 4
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2011-02-23
Last Posted Date
2016-12-29
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
32
Registration Number
NCT01301729

Taxotere®, Eloxatin® and Xeloda® (TEX) in Combination With Herceptin® as Treatment for HER2 Positive Non-resectable Cancer

Not Applicable
Completed
Conditions
Adenocarcinoma
Interventions
First Posted Date
2011-02-14
Last Posted Date
2020-11-02
Lead Sponsor
Odense University Hospital
Target Recruit Count
27
Registration Number
NCT01295086
Locations
🇩🇰

Aalborg University Hospital, Aalborg, Denmark

🇩🇰

Aarhus University Hospital, Aarhus, Denmark

🇩🇰

Rigshospitalet, Copenhagen, Denmark

and more 1 locations

A Study of AT-101 in Combination With Docetaxel in Squamous Cell Carcinoma Of The Head and Neck

Phase 2
Terminated
Conditions
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Interventions
Drug: AT-101
Drug: Docetaxel
First Posted Date
2011-01-28
Last Posted Date
2016-03-31
Lead Sponsor
University of Michigan Rogel Cancer Center
Target Recruit Count
35
Registration Number
NCT01285635
Locations
🇺🇸

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

🇺🇸

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

A Safety Study in Participants With Advanced Solid Tumors

First Posted Date
2011-01-27
Last Posted Date
2019-01-10
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
234
Registration Number
NCT01284335
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., Yakima, Washington, United States

Study of Ramucirumab or Icrucumab (IMC-18F1) With Docetaxel or Docetaxel Alone as Second-Line Therapy in Participants With Bladder,Urethra, Ureter, or Renal Pelvis Carcinoma

Phase 2
Completed
Conditions
Carcinoma of Urinary Tract
Urethral Carcinoma
Carcinoma of Ureter
Carcinoma of Renal Pelvis
Interventions
Drug: Docetaxel
Biological: Ramucirumab DP
Biological: Icrucumab
First Posted Date
2011-01-25
Last Posted Date
2019-09-09
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
148
Registration Number
NCT01282463
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., Toronto, Ontario, Canada

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