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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Phase III Study of Two Different Schedules (Weekly and Tri-weekly) of Combination of Gemcitabine and Two Taxanes in MBC

Phase 3
Completed
Conditions
Metastatic Breast Cancer (MBC)
Interventions
First Posted Date
2005-10-12
Last Posted Date
2011-09-27
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
241
Registration Number
NCT00236899
Locations
🇮🇹

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Viterbo, Italy

Docetaxel in Treating Older Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Phase 2
Completed
Conditions
Lung Cancer
First Posted Date
2005-09-28
Last Posted Date
2020-02-13
Lead Sponsor
UNICANCER
Target Recruit Count
58
Registration Number
NCT00227708
Locations
🇨🇭

Clinique De Genolier, Genolier, Switzerland

🇫🇷

Centre Hospitalier Intercommunal St. Aubin les Elbeuf, Elbeuf, France

🇬🇧

Charing Cross Hospital, London, England, United Kingdom

and more 6 locations

Gemcitabine and Docetaxel in Treating Patients With Relapsed or Refractory Ovarian Epithelial or Peritoneal Cancer

Phase 2
Completed
Conditions
Ovarian Cancer
Peritoneal Cavity Cancer
Interventions
Drug: Docetaxel
Drug: Gemcitabine hydrochloride
First Posted Date
2005-09-28
Last Posted Date
2020-12-02
Lead Sponsor
Robert Morris
Target Recruit Count
30
Registration Number
NCT00227721
Locations
🇺🇸

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

🇺🇸

Northern Virginia Pelvic Surgery Assoc, Annandale, Virginia, United States

🇺🇸

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus, Ohio, United States

and more 1 locations

Gemcitabine With or Without Docetaxel as Second-Line Therapy in Treating Patients With Metastatic or Relapsed, Unresectable Uterine or Soft Tissue Leiomyosarcoma

Phase 2
Completed
Conditions
Sarcoma
Interventions
Drug: gemcitabine hydrochloride
Drug: docetaxel
First Posted Date
2005-09-28
Last Posted Date
2016-08-30
Lead Sponsor
UNICANCER
Target Recruit Count
90
Registration Number
NCT00227669
Locations
🇫🇷

Centre Paul Papin, Angers, France

🇫🇷

Centre Hospitalier Universitaire d'Amiens, Amiens, France

🇫🇷

C.H.G. Beauvais, Beauvais, France

and more 29 locations

Docetaxel, Cetuximab and Cisplatin Followed by Radiation, Cetuximab and Cisplatin in Head and Neck Cancer

Phase 2
Completed
Conditions
Cancer
Interventions
First Posted Date
2005-09-26
Last Posted Date
2017-07-11
Lead Sponsor
University of Pittsburgh
Target Recruit Count
39
Registration Number
NCT00226239
Locations
🇺🇸

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States

Docetaxel, Androgen Ablation, and External-Beam Radiation Therapy in Patients With High-Risk Localized Prostate Cancer

Phase 1
Completed
Conditions
Prostate Cancer
Interventions
Drug: docetaxel
Drug: leuprolide acetate
Radiation: radiation therapy
First Posted Date
2005-09-23
Last Posted Date
2017-06-01
Lead Sponsor
UNC Lineberger Comprehensive Cancer Center
Target Recruit Count
23
Registration Number
NCT00225420
Locations
🇺🇸

Rex Cancer Center at Rex Hospital, Raleigh, North Carolina, United States

🇺🇸

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States

Bi-Weekly Administration of Docetaxel for Older Men With Hormone Refractory Prostate Cancer

Phase 1
Completed
Conditions
Prostate Cancer
First Posted Date
2005-09-22
Last Posted Date
2007-11-19
Lead Sponsor
Geriatric Oncology Consortium
Target Recruit Count
17
Registration Number
NCT00215709

Docetaxel and Carboplatin in Treating Patients With Relapsed Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cavity Cancer

Phase 2
Completed
Conditions
Ovarian Cancer
Peritoneal Cavity Cancer
First Posted Date
2005-09-22
Last Posted Date
2010-09-21
Lead Sponsor
Fred Hutchinson Cancer Center
Registration Number
NCT00217568
Locations
🇺🇸

University of Washington School of Medicine, Seattle, Washington, United States

🇺🇸

Pacific Gynecology Specialists, Seattle, Washington, United States

🇺🇸

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

Bevacizumab, Oxaliplatin, and Docetaxel in Treating Patients With Locally Advanced Unresectable or Metastatic Stomach or Gastroesophageal Junction Cancer

Phase 2
Completed
Conditions
Esophageal Cancer
Gastric Cancer
Interventions
Biological: Bevacizumab
Drug: Docetaxel
Drug: Oxaliplatin
First Posted Date
2005-09-22
Last Posted Date
2019-03-26
Lead Sponsor
Barbara Ann Karmanos Cancer Institute
Target Recruit Count
39
Registration Number
NCT00217581
Locations
🇺🇸

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus, Ohio, United States

🇺🇸

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

🇺🇸

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

and more 1 locations

Docetaxel With Bevacizumab as First-Line Therapy in Treating Women With Stage IV Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
Biological: bevacizumab
Drug: Docetaxel
First Posted Date
2005-09-22
Last Posted Date
2020-08-05
Lead Sponsor
Translational Oncology Research International
Target Recruit Count
76
Registration Number
NCT00217672
Locations
🇺🇸

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

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