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

Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer

Phase 1
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2003-08-07
Last Posted Date
2023-08-04
Lead Sponsor
NCIC Clinical Trials Group
Target Recruit Count
93
Registration Number
NCT00066443
Locations
🇨🇦

Atlantic Health Sciences Corporation, Saint John, New Brunswick, Canada

🇨🇦

Univ. Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada

🇨🇦

CHA-Hopital Du St-Sacrement, Quebec City, Quebec, Canada

and more 2 locations

Comparison of IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Stage IIIB/IV Non-Small Cell Lung Cancer

Phase 2
Completed
Conditions
Lung Cancer, Non-Small Cell
Non-Small-Cell Lung Cancer
First Posted Date
2003-07-18
Last Posted Date
2019-06-24
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
399
Registration Number
NCT00065182
Locations
🇵🇱

GSK Investigational Site, Szczecin Zdunowo 20, Poland

Oblimersen Plus Doxorubicin and Docetaxel in Treating Patients With Metastatic or Locally Advanced Breast Cancer

Phase 1
Terminated
Conditions
Stage IIIC Breast Cancer
Male Breast Cancer
Stage IIIB Breast Cancer
Stage IIIA Breast Cancer
Stage IV Breast Cancer
Interventions
Biological: oblimersen sodium
Biological: filgrastim
Biological: pegfilgrastim
Procedure: therapeutic conventional surgery
Other: pharmacological study
Other: laboratory biomarker analysis
First Posted Date
2003-07-09
Last Posted Date
2019-03-05
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
31
Registration Number
NCT00063934
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer

Phase 2
Completed
Conditions
Lung Cancer
Interventions
First Posted Date
2003-07-09
Last Posted Date
2019-12-13
Lead Sponsor
University of Wisconsin, Madison
Target Recruit Count
4
Registration Number
NCT00064012
Locations
🇺🇸

Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, United States

🇺🇸

Siteman Cancer Center, Saint Louis, Missouri, United States

🇺🇸

St. Louis University Hospital Cancer Center, Saint Louis, Missouri, United States

and more 18 locations

Combination Chemotherapy in Treating Women With Stage IIIB or Stage IV Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
First Posted Date
2003-06-27
Last Posted Date
2012-12-11
Lead Sponsor
NSABP Foundation Inc
Target Recruit Count
89
Registration Number
NCT00003352
Locations
🇺🇸

Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States

🇺🇸

University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States

🇺🇸

Veterans Affairs Medical Center - Pittsburgh, Pittsburgh, Pennsylvania, United States

and more 163 locations

Monoclonal Antibody Therapy and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer

Phase 2
Terminated
Conditions
Breast Cancer
First Posted Date
2003-06-27
Last Posted Date
2011-10-24
Lead Sponsor
Seagen Inc.
Registration Number
NCT00028483
Locations
🇺🇸

University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States

Docetaxel in Treating Patients With Recurrent or Refractory Ovarian or Primary Peritoneal Cancer

Phase 2
Terminated
Conditions
Ovarian Cancer
Primary Peritoneal Cavity Cancer
First Posted Date
2003-06-25
Last Posted Date
2013-04-11
Lead Sponsor
Gynecologic Oncology Group
Registration Number
NCT00004037
Locations
🇺🇸

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

🇺🇸

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States

🇺🇸

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

and more 64 locations

Combination Chemotherapy Plus Bevacizumab in Treating Patients With Metastatic Prostate Cancer

Phase 2
Completed
Conditions
Adenocarcinoma of the Prostate
Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Interventions
Biological: bevacizumab
Other: laboratory biomarker analysis
First Posted Date
2003-06-10
Last Posted Date
2013-06-05
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
72
Registration Number
NCT00016107
Locations
🇺🇸

Cancer and Leukemia Group B, Chicago, Illinois, United States

S0220: Chemoradiotherapy Followed By Surgery and Docetaxel in Treating Patients With Pancoast Tumors

Phase 2
Completed
Conditions
Lung Cancer
Interventions
Procedure: conventional surgery
Radiation: radiation therapy
First Posted Date
2003-06-06
Last Posted Date
2013-11-25
Lead Sponsor
SWOG Cancer Research Network
Target Recruit Count
46
Registration Number
NCT00062439
Locations
🇺🇸

Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, United States

🇺🇸

Holland Community Hospital, Holland, Michigan, United States

🇺🇸

Providence Cancer Institute at Providence Hospital - Southfield Campus, Southfield, Michigan, United States

and more 150 locations

Neoadjuvant Chemoradiotherapy With or Without Gefitinib in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer

Phase 1
Completed
Conditions
Lung Cancer
First Posted Date
2003-06-06
Last Posted Date
2015-10-08
Lead Sponsor
University of Alabama at Birmingham
Registration Number
NCT00062270
Locations
🇺🇸

University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States

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