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

Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-small Cell Lung Cancer

Phase 2
Completed
Conditions
Lung Cancer
First Posted Date
2003-05-21
Last Posted Date
2012-07-18
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Target Recruit Count
47
Registration Number
NCT00005868
Locations
🇳🇱

Leiden University Medical Center, Leiden, Netherlands

🇮🇹

Istituto Nazionale per la Ricerca sul Cancro, Genoa (Genova), Italy

🇳🇱

Groot Ziekengasthuis 's-Hertogenbosch, 's-Hertogenbosch, Netherlands

and more 20 locations

Combination Chemotherapy in Treating Patients With Stage IV Locally Advanced or Metastatic Bladder Cancer

Phase 2
Completed
Conditions
Bladder Cancer
Interventions
First Posted Date
2003-05-16
Last Posted Date
2013-09-05
Lead Sponsor
University of Chicago
Target Recruit Count
6
Registration Number
NCT00005086
Locations
🇺🇸

Louis A. Weiss Memorial Hospital, Chicago, Illinois, United States

🇺🇸

Fort Wayne Medical Oncology and Hematology, Inc., Fort Wayne, Indiana, United States

🇺🇸

University of Chicago Cancer Research Center, Chicago, Illinois, United States

and more 1 locations

Docetaxel in Treating Older Patients With Metastatic Breast, Lung, or Prostate Cancer

Phase 2
Completed
Conditions
Breast Cancer
Lung Cancer
Prostate Cancer
First Posted Date
2003-05-07
Last Posted Date
2013-01-16
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Registration Number
NCT00059943
Locations
🇺🇸

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Docetaxel and Oxaliplatin in Treating Patients With Metastatic or Recurrent Solid Tumor

Phase 1
Completed
Conditions
Unspecified Adult Solid Tumor, Protocol Specific
First Posted Date
2003-04-18
Last Posted Date
2010-01-13
Lead Sponsor
City of Hope Medical Center
Registration Number
NCT00004243
Locations
🇺🇸

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

🇺🇸

Beckman Research Institute, City of Hope, Los Angeles, California, United States

🇺🇸

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

S0224, Docetaxel in Treating Patients With Locally Advanced or Metastatic Penile Cancer (TERMINATED)

Phase 2
Terminated
Conditions
Penile Cancer
First Posted Date
2003-04-09
Last Posted Date
2018-06-28
Lead Sponsor
SWOG Cancer Research Network
Target Recruit Count
1
Registration Number
NCT00058448
Locations
🇺🇸

Kalispell Regional Medical Center, Kalispell, Montana, United States

🇺🇸

Riverside Methodist Hospital Cancer Care, Columbus, Ohio, United States

🇺🇸

Rose Ramer Cancer Clinic at Anderson Area Medical Center, Anderson, South Carolina, United States

and more 46 locations

Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors

Phase 1
Completed
Conditions
Stage IV Prostate Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Recurrent Prostate Cancer
Interventions
First Posted Date
2003-04-09
Last Posted Date
2014-06-17
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
80
Registration Number
NCT00058253
Locations
🇺🇸

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse

Phase 3
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2003-03-07
Last Posted Date
2023-01-18
Lead Sponsor
UNICANCER
Target Recruit Count
413
Registration Number
NCT00055731
Locations
🇫🇷

Centre Paul Papin, Angers, France

🇫🇷

Hopital Saint Andre, Bordeaux, France

🇫🇷

Institut Bergonie, Bordeaux, France

and more 35 locations

Bevacizumab and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer

Phase 2
Completed
Conditions
Recurrent Breast Cancer
Stage IV Breast Cancer
Interventions
Biological: bevacizumab
Other: laboratory biomarker analysis
First Posted Date
2003-03-07
Last Posted Date
2013-06-04
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
27
Registration Number
NCT00055861
Locations
🇺🇸

Ohio State University Medical Center, Columbus, Ohio, United States

🇺🇸

University of Colorado Cancer Center - Anschutz Cancer Pavilion, Aurora, Colorado, United States

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

Phase 1
Completed
Conditions
Recurrent Squamous Cell Carcinoma of the Hypopharynx
Stage IV Squamous Cell Carcinoma of the Hypopharynx
Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IV Squamous Cell Carcinoma of the Nasopharynx
Stage IV Squamous Cell Carcinoma of the Oropharynx
Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Recurrent Salivary Gland Cancer
Recurrent Squamous Cell Carcinoma of the Oropharynx
Recurrent Squamous Cell Carcinoma of the Larynx
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
Interventions
Other: laboratory biomarker analysis
Other: pharmacological study
First Posted Date
2003-03-07
Last Posted Date
2013-11-25
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
45
Registration Number
NCT00055770
Locations
🇺🇸

Ohio State University Medical Center, Columbus, Ohio, United States

S0216, Combination Chemotherapy and RT in Treating Patients With Stage III or Stage IV Head and Neck Cancer

Phase 2
Completed
Conditions
Head and Neck Cancer
First Posted Date
2003-02-06
Last Posted Date
2011-07-25
Lead Sponsor
SWOG Cancer Research Network
Registration Number
NCT00054054
Locations
🇺🇸

MBCCOP - Gulf Coast, Mobile, Alabama, United States

🇺🇸

CCOP - Atlanta Regional, Atlanta, Georgia, United States

🇺🇸

Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, United States

and more 92 locations
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