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
-

Chloroquine With Taxane Chemotherapy for Advanced or Metastatic Breast Cancer After Anthracycline Failure (CAT)

Phase 2
Completed
Conditions
Breast Neoplasms
Breast Cancer
Interventions
First Posted Date
2011-10-04
Last Posted Date
2023-01-23
Lead Sponsor
The Methodist Hospital Research Institute
Target Recruit Count
38
Registration Number
NCT01446016
Locations
🇺🇸

Houston Methodist Hospital Sugar Land, Sugar Land, Texas, United States

🇺🇸

Houston Methodist Hospital Cancer Center, Houston, Texas, United States

🇺🇸

Houston Methodist Hospital Willowbrook, Houston, Texas, United States

Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN)

First Posted Date
2011-09-29
Last Posted Date
2018-08-09
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
42
Registration Number
NCT01443078
Locations
🇺🇸

Memorial Sloan-Kettering at Mercy Medical Center, Rockville Centre, New York, United States

🇺🇸

Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center, Sleepy Hollow, New York, United States

🇺🇸

Memoral Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States

and more 2 locations

Docetaxel, Cisplatin, and Cetuximab (TPC) in Palliative Treatment of Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Phase 2
Completed
Conditions
Head and Neck Cancer
Interventions
First Posted Date
2011-09-20
Last Posted Date
2024-01-30
Lead Sponsor
Stanford University
Target Recruit Count
27
Registration Number
NCT01437449
Locations
🇺🇸

Stanford University, School of Medicine, Stanford, California, United States

🇺🇸

University of California Davis Medical Center, Davis, California, United States

Pazopanib, Docetaxel, Prednisone Prostate

Phase 1
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2011-06-30
Last Posted Date
2018-06-06
Lead Sponsor
Daniel George, MD
Target Recruit Count
36
Registration Number
NCT01385228
Locations
🇺🇸

Duke Cancer Institute, Durham, North Carolina, United States

🇺🇸

The University of Chicago, Chicago, Illinois, United States

Docetaxel and Lapatinib in Metastatic Transitional Cell Carcinoma in Bladder

Phase 2
Terminated
Conditions
Recurrent Bladder Cancer
Stage III Bladder Cancer
Stage IV Bladder Cancer
Transitional Cell Carcinoma of the Bladder
Interventions
Drug: docetaxel
Drug: lapatinib ditosylate
Other: immunohistochemistry staining method
Genetic: fluorescence in situ hybridization
Other: laboratory biomarker analysis
First Posted Date
2011-06-27
Last Posted Date
2018-05-16
Lead Sponsor
University of Southern California
Target Recruit Count
15
Registration Number
NCT01382706
Locations
🇺🇸

USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States

Study of Lenalidomide and Docetaxel in Subjects With Androgen Independent Prostate Cancer

Phase 1
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2011-06-22
Last Posted Date
2016-05-09
Lead Sponsor
Columbia University
Target Recruit Count
64
Registration Number
NCT01378091
Locations
🇺🇸

Cornell Weill Medical Center, New York, New York, United States

🇺🇸

Columbia University Medical Center, New York, New York, United States

Combination of Cisplatin, Docetaxel and Bevacizumab in Patients With Non-small Cell Lung Carcinoma (NSCLC)

Phase 2
Completed
Conditions
NSCLC
First Posted Date
2011-06-08
Last Posted Date
2013-08-30
Lead Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Target Recruit Count
7
Registration Number
NCT01368848
Locations
🇦🇹

Landeskrankenhaus Feldkirch, Feldkirch, Vorarlberg, Austria

🇦🇹

Univ.-Klinik für Innere Medizin V Innsbruck, Abteilung für Hämatologie und Onkologie, Innsbruck, Tirol, Austria

🇦🇹

Universitaetsklinik der PMU Salzburg, UK f. Innere Medizin III, Salzburg, Austria

An Open-label Study of GSK1120212 Compared With Docetaxel in Stage IV KRAS-mutant Non-small Cell Lung Cancer

Phase 2
Completed
Conditions
Lung Cancer, Non-Small Cell
Interventions
First Posted Date
2011-05-30
Last Posted Date
2014-07-11
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
134
Registration Number
NCT01362296
Locations
🇪🇸

GSK Investigational Site, Pamplona, Spain

Safety and Clinical Pharmacology of GDC-0068 in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin, Paclitaxel, or Enzalutamide in Participants With Advanced Solid Tumors

First Posted Date
2011-05-30
Last Posted Date
2022-01-12
Lead Sponsor
Genentech, Inc.
Target Recruit Count
122
Registration Number
NCT01362374
Locations
🇫🇷

Institut Gustave Roussy; Departement Oncologie Medicale, Villejuif, France

🇺🇸

Florida Cancer Specialists - Sarasota, Sarasota, Florida, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

and more 8 locations

A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer

First Posted Date
2011-05-24
Last Posted Date
2024-06-14
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
4804
Registration Number
NCT01358877
Locations
🇺🇸

Texas Oncology - DFW, Dallas, Texas, United States

🇺🇸

The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc., Columbus, Ohio, United States

🇺🇸

Rush University Medical Center, Chicago, Illinois, United States

and more 552 locations
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