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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ADAPT - Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer

Phase 2
Active, not recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2013-01-30
Last Posted Date
2024-11-12
Lead Sponsor
West German Study Group
Target Recruit Count
4936
Registration Number
NCT01779206
Locations
🇩🇪

Ev. Krankenhaus Bethesda Brustzentrum Niederrhein, Mönchengladbach, NRW, Germany

🇩🇪

Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern, Munich, Bavaria, Germany

Effect of Trastuzumab on Disease Free Survival in Early Stage HER2-Negative Breast Cancer Patients With ERBB2 Expressing Disseminated Tumor Cells

First Posted Date
2013-01-29
Last Posted Date
2022-11-01
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
7
Registration Number
NCT01779050
Locations
🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

XEBRA Study: An Observational Study of Xeloda (Capecitabine) in Combination With Docetaxel in First Line in Participants With HER2-Negative Metastatic Breast Cancer

Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2013-01-29
Last Posted Date
2016-08-19
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
46
Registration Number
NCT01777945

Immunotherapy Study in Progressive or Relapsed Non-Small Cell Lung Cancer

Phase 2
Terminated
Conditions
Non-small Cell Lung Cancer Recurrent
Non-small Cell Lung Cancer
Progression of Non-small Cell Lung Cancer
Interventions
Drug: Docetaxel
Biological: HyperAcute®-Lung Immunotherapy
Drug: Gemcitabine
Drug: Pemetrexed
First Posted Date
2013-01-24
Last Posted Date
2020-05-28
Lead Sponsor
NewLink Genetics Corporation
Target Recruit Count
135
Registration Number
NCT01774578
Locations
🇺🇸

St. Joseph Heritage Healthcare, Santa Rosa, California, United States

🇺🇸

Illinois Cancer Specialists, Arlington Heights, Illinois, United States

🇺🇸

Deaconess Clinic, Evansville, Indiana, United States

and more 21 locations

Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line to Treat Biliary Cancer

Phase 2
Terminated
Conditions
Biliary Cancer
Interventions
Drug: SPI-1620
Drug: Docetaxel
First Posted Date
2013-01-23
Last Posted Date
2021-10-13
Lead Sponsor
Spectrum Pharmaceuticals, Inc
Target Recruit Count
30
Registration Number
NCT01773785
Locations
🇺🇸

University of Miami Hospitals & Clinics/ Sylvester Comprehensive Cancer Center, Miami, Florida, United States

🇺🇸

Seattle Cancer Care Alliance, Seattle, Washington, United States

🇺🇸

Associates in Oncology and Hematology, Chattanooga, Tennessee, United States

and more 3 locations

Paclitaxel-bevacizumab in Advanced Lung Cancer

Phase 3
Completed
Conditions
Non-squamous Non-small Cell Lung Cancer
Interventions
First Posted Date
2013-01-09
Last Posted Date
2023-03-14
Lead Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Target Recruit Count
166
Registration Number
NCT01763671
Locations
🇫🇷

CHI Créteil, Créteil, France

🇫🇷

Hôpital Privé d'Antony, Antony, France

🇫🇷

CH Compiègne - Pneumologie, Compiègne, France

and more 51 locations

Gefitinib or Docetaxel as Second Line Therapy for Wild-type Epidermal Growth Factor Receptor (EGFR) NSCLC

Phase 2
Conditions
Non-small Cell Lung Cancer
Interventions
First Posted Date
2012-12-24
Last Posted Date
2012-12-24
Lead Sponsor
Peking Union Medical College Hospital
Target Recruit Count
60
Registration Number
NCT01755923
Locations
🇨🇳

Department of Respiratory Medicine, Peking Union Medical College Hospita, Beijing, Beijing, China

GTX-RT in Borderline Resectable Pancreatic Cancer

Phase 2
Terminated
Conditions
Pancreatic Cancer
Interventions
Drug: Capecitabine
Drug: Gemcitabine
Drug: Docetaxel
Radiation: Stereotactic body radiation therapy (SBRT)
Other: Restaging review after radiation
Procedure: Surgery
Drug: 5-Fluorouracil
First Posted Date
2012-12-21
Last Posted Date
2015-08-13
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
9
Registration Number
NCT01754623
Locations
🇺🇸

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Cisplatin,Docetaxel and S-1 for Advanced Gastric and Gastroesophageal Junction Cancer

Phase 2
Conditions
Gastric Cancer
Gastroesophageal Junction Cancer
Interventions
First Posted Date
2012-12-12
Last Posted Date
2012-12-12
Lead Sponsor
Chinese Academy of Medical Sciences
Target Recruit Count
40
Registration Number
NCT01747707
Locations
🇨🇳

Cancer Hospital & Institute, Chinese Academy of Medical Sciences, Beijing, China

Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer (NSCLC)

Phase 2
Terminated
Conditions
Non Small Cell Lung Cancer (NSCLC)
Interventions
Drug: SPI-1620
Drug: Docetaxel
First Posted Date
2012-12-04
Last Posted Date
2021-10-13
Lead Sponsor
Spectrum Pharmaceuticals, Inc
Target Recruit Count
34
Registration Number
NCT01741155
Locations
🇺🇸

The Center for Cancer and Blood Disorders, Fort Worth, Texas, United States

🇺🇸

Virginia Cancer Institute, Richmond, Virginia, United States

🇺🇸

Oncology Hematology Care Inc., Cincinnati, Ohio, United States

and more 2 locations
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