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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
-

Docetaxel and Temozolomide in Treating Patients With Metastatic Cancer

Phase 1
Completed
Conditions
Unspecified Adult Solid Tumor, Protocol Specific
First Posted Date
2006-11-17
Last Posted Date
2011-07-08
Lead Sponsor
The Cleveland Clinic
Target Recruit Count
25
Registration Number
NCT00401180
Locations
🇺🇸

Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil

Phase 2
Terminated
Conditions
Squamous Cell Carcinoma
Oral Cancer
Interventions
First Posted Date
2006-11-16
Last Posted Date
2017-11-06
Lead Sponsor
Emory University
Target Recruit Count
14
Registration Number
NCT00400205
Locations
🇺🇸

Emory University Winship Cancer Institute, Atlanta, Georgia, United States

Phase I Trial of Docetaxel With Perifosine

Phase 1
Completed
Conditions
Neoplasms
Interventions
First Posted Date
2006-11-14
Last Posted Date
2014-02-13
Lead Sponsor
AEterna Zentaris
Target Recruit Count
39
Registration Number
NCT00399087
Locations
🇺🇸

Investigative Site, Johnson City, Tennessee, United States

Docetaxel, Epirubicin, and Cyclophosphamide With or Without Trastuzumab in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery

Phase 2
Conditions
Breast Cancer
First Posted Date
2006-11-10
Last Posted Date
2010-11-09
Lead Sponsor
Technical University of Munich
Target Recruit Count
94
Registration Number
NCT00398489
Locations
🇩🇪

Klinikum Rechts Der Isar - Technische Universitaet Muenchen, Munich, Germany

🇩🇪

Klinikum Deggendorf, Deggendorf, Germany

🇩🇪

Universitaetsfrauenklinik - Koeln, Cologne, Germany

and more 2 locations

Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer

Phase 2
Completed
Conditions
Esophageal Cancer
Stomach Cancer
Interventions
First Posted Date
2006-11-01
Last Posted Date
2017-08-01
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
38
Registration Number
NCT00394433
Locations
🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Carbon-11 Acetate and Fludeoxyglucose F 18 PET Scan of the Bone in Patients With Metastatic Prostate Cancer That Has Spread to the Bone

Completed
Conditions
Metastatic Cancer
Prostate Cancer
First Posted Date
2006-10-26
Last Posted Date
2017-03-13
Lead Sponsor
University of Washington
Target Recruit Count
11
Registration Number
NCT00392938
Locations
🇺🇸

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

🇺🇸

University of Washington School of Medicine, Seattle, Washington, United States

Chemotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)

Phase 3
Completed
Conditions
Non-Small Cell Lung Cancer
Interventions
First Posted Date
2006-10-23
Last Posted Date
2011-04-12
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
211
Registration Number
NCT00391274
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., Wu Han, China

A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer.

Phase 3
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2006-10-23
Last Posted Date
2015-08-28
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
424
Registration Number
NCT00391092

Docetaxel and Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer or Other Solid Tumors

Phase 1
Completed
Conditions
Lung Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
First Posted Date
2006-10-19
Last Posted Date
2018-12-06
Lead Sponsor
University of California, Davis
Target Recruit Count
81
Registration Number
NCT00390429
Locations
🇺🇸

University of California Davis Cancer Center, Sacramento, California, United States

A Phase 2 Study in Patients With Advanced Non-Small Cell Lung Cancer Using New Agents With and Without Docetaxel.

Phase 2
Withdrawn
Conditions
Carcinoma, Non-Small-Cell Lung
First Posted Date
2006-10-11
Last Posted Date
2012-08-09
Lead Sponsor
Arog Pharmaceuticals, Inc.
Registration Number
NCT00386555
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