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

Estramustine, Docetaxel, and Carboplatin in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

Phase 1
Completed
Conditions
Prostate Cancer
First Posted Date
2003-01-27
Last Posted Date
2013-07-18
Lead Sponsor
Dana-Farber Cancer Institute
Registration Number
NCT00005627
Locations
🇺🇸

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

🇺🇸

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

Docetaxel and Flavopiridol in Treating Patients With Locally Advanced or Metastatic Breast Cancer

Phase 1
Completed
Conditions
Breast Cancer
First Posted Date
2003-01-27
Last Posted Date
2013-06-17
Lead Sponsor
National Cancer Institute (NCI)
Registration Number
NCT00020332
Locations
🇺🇸

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland, United States

Phase II Bevacizumab + Tax In Advanced Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
Biological: bevacizumab
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
First Posted Date
2003-01-27
Last Posted Date
2013-06-17
Lead Sponsor
Case Comprehensive Cancer Center
Target Recruit Count
49
Registration Number
NCT00027885
Locations
🇺🇸

UH-Southwest, Middleburgh Heights, Ohio, United States

🇺🇸

UH-Green Road, South Euclid, Ohio, United States

🇺🇸

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

and more 2 locations

S0215 Trastuzumab, Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
Biological: filgrastim
Biological: trastuzumab
First Posted Date
2003-01-27
Last Posted Date
2013-06-06
Lead Sponsor
SWOG Cancer Research Network
Target Recruit Count
76
Registration Number
NCT00041067
Locations
🇺🇸

Northern Rockies Radiation Oncology Center, Billings, Montana, United States

🇺🇸

Great Falls Clinic, Great Falls, Montana, United States

🇺🇸

Billings Clinic Cancer Center, Billings, Montana, United States

and more 142 locations

Docetaxel in Treating Patients With Non-Small Cell Lung Cancer

Phase 3
Conditions
Lung Cancer
First Posted Date
2003-01-27
Last Posted Date
2013-12-18
Lead Sponsor
Istituto Nazionale per lo Studio e la Cura dei Tumori
Target Recruit Count
200
Registration Number
NCT00022022
Locations
🇮🇹

Istituto Di Ricovero E Cura A Carattere Scientifico, Bari, Italy

🇮🇹

Ospedale San Paolo, Milano, Italy

🇮🇹

Ospedale Luigi Sacco, Milan, Italy

and more 13 locations

Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer

Phase 2
Conditions
Breast Cancer
First Posted Date
2003-01-27
Last Posted Date
2013-08-07
Lead Sponsor
Grupo Oncologico Cooperativo del Sur
Target Recruit Count
42
Registration Number
NCT00026078
Locations
🇦🇷

C.R I O., Mar del Plata, Argentina

🇦🇷

Centro Oncologico Tres Arroyos, Tres Arroyos, Argentina

🇦🇷

Unidad Oncologica Del Neuquen, Neuquen, Argentina

and more 5 locations

Paclitaxel or Docetaxel in Treating Women With Advanced Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
First Posted Date
2003-01-27
Last Posted Date
2013-08-02
Lead Sponsor
Aventis Pharmaceuticals
Registration Number
NCT00002662
Locations
🇺🇸

George Washington University Medical Center, Washington, District of Columbia, United States

🇺🇸

Baptist Regional Cancer Institute - Jacksonville, Jacksonville, Florida, United States

🇺🇸

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

and more 29 locations

Mitoxantrone With or Without Docetaxel in Treating Women With Metastatic Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
First Posted Date
2003-01-27
Last Posted Date
2013-08-02
Lead Sponsor
Arbeitsgemeinschaft fur Internistische Onkologie
Target Recruit Count
300
Registration Number
NCT00002544
Locations
🇩🇪

Diakonissen-Krankenhaus Stuttgart, Stuttgart, Germany

Biomarker (p53 Gene) Analysis and Combination Chemotherapy Followed by Radiation Therapy and Surgery in Treating Women With Large Operable or Locally Advanced or Inflammatory Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
Interventions
Biological: filgrastim
Genetic: microarray analysis
Other: laboratory biomarker analysis
Other: immunohistochemistry staining method
Procedure: biopsy
Procedure: neoadjuvant therapy
Procedure: conventional surgery
Radiation: radiation therapy
First Posted Date
2003-01-27
Last Posted Date
2013-10-24
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Target Recruit Count
1856
Registration Number
NCT00017095
Locations
🇬🇧

Edinburgh Cancer Centre at Western General Hospital, Edinburgh, Scotland, United Kingdom

🇵🇹

Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A., Lisbon, Portugal

🇨🇭

Inselspital Bern, Bern, Switzerland

and more 36 locations

Docetaxel With or Without Infliximab in Treating Weight Loss, Loss of Appetite, and Fatigue in Patients With Unresectable Non-Small Cell Lung Cancer (Infliximab Treatment Discontinued Effective 10/05/05)

Phase 3
Completed
Conditions
Anorexia
Cachexia
Fatigue
Lung Cancer
Interventions
Biological: infliximab
Other: placebo
First Posted Date
2003-01-27
Last Posted Date
2016-12-07
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
67
Registration Number
NCT00040885
Locations
🇺🇸

Hope Cancer Care Center at Longmont United Hospital, Longmont, Colorado, United States

🇺🇸

St. Mary-Corwin Regional Medical Center, Pueblo, Colorado, United States

🇺🇸

Mason District Hospital, Havana, Illinois, United States

and more 184 locations
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