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
-

Study of Docetaxel +153 Sm-EDTMP in Patients With Hormone-Refractory Prostate Cancer

Phase 1
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2007-11-16
Last Posted Date
2008-12-17
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Target Recruit Count
13
Registration Number
NCT00559429
Locations
🇺🇸

The Harry and Jeanette Weinberg Building, Baltimore, Maryland, United States

Docetaxel and Prednisolone With or Without Zoledronic Acid and/or Strontium Chloride Sr 89 in Treating Patients With Prostate Cancer Metastatic to Bone That Has Not Responded to Hormone Therapy

Phase 2
Completed
Conditions
Prostate Cancer
Metastatic Cancer
First Posted Date
2007-11-07
Last Posted Date
2013-08-07
Lead Sponsor
University Hospital Birmingham
Target Recruit Count
300
Registration Number
NCT00554918
Locations
🇬🇧

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust, Birmingham, England, United Kingdom

🇬🇧

Gloucestershire Oncology Centre at Cheltenham General Hospital, Cheltenham, England, United Kingdom

🇬🇧

Christie Hospital, Manchester, England, United Kingdom

and more 13 locations

Chemotherapy, Radiation Therapy, and Cetuximab Followed by Surgery, Docetaxel, and Cetuximab in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer

Phase 2
Terminated
Conditions
Esophageal Cancer
Interventions
First Posted Date
2007-10-31
Last Posted Date
2023-07-03
Lead Sponsor
Eastern Cooperative Oncology Group
Target Recruit Count
22
Registration Number
NCT00551759
Locations
🇺🇸

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States

🇺🇸

Hematology and Oncology Associates, Chicago, Illinois, United States

🇺🇸

Southwest Medical Center, Liberal, Kansas, United States

and more 106 locations

A Phase I Study of Intravenous Aflibercept in Combination With Docetaxel in Japanese Cancer Patients

Phase 1
Completed
Conditions
Neoplasms
Interventions
First Posted Date
2007-10-17
Last Posted Date
2013-10-16
Lead Sponsor
Sanofi
Target Recruit Count
12
Registration Number
NCT00545246
Locations
🇯🇵

Sanofi-Aventis Investigational Site Number 392001, Sunto-Gun, Japan

🇯🇵

Sanofi-Aventis Investigational Site Number 392002, Iruma-gun, Japan

A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.

Phase 2
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2007-10-17
Last Posted Date
2017-08-15
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
417
Registration Number
NCT00545688
Locations
🇦🇺

Geelong Hospital; Andrew Love Cancer Centre, Geelong, Victoria, Australia

🇲🇽

ARKE Estudios Clínicos S.A. de C.V., Mexico City, Mexico

🇮🇱

Meir Medical Center; Oncology, Kfar-Saba, Israel

and more 74 locations

Chemotherapy Followed by Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Locally Advanced Head And Neck Cancer

Phase 2
Active, not recruiting
Conditions
Head and Neck Cancer
Interventions
Drug: cisplatin
Drug: docetaxel
Drug: fluorouracil
Drug: gemcitabine hydrochloride
Drug: leucovorin calcium
Genetic: gene expression analysis
Genetic: protein expression analysis
Other: laboratory biomarker analysis
Procedure: adjuvant therapy
Procedure: biopsy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Procedure: quality-of-life assessment
Radiation: radiation therapy
First Posted Date
2007-10-16
Last Posted Date
2024-02-29
Lead Sponsor
City of Hope Medical Center
Target Recruit Count
31
Registration Number
NCT00544414

Treatment of Participants With Advanced and/or Refractory Solid Tumors (MK-5108-001)

Phase 1
Completed
Conditions
Cancer, Neoplasms, Tumors
Interventions
First Posted Date
2007-10-15
Last Posted Date
2024-06-05
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
35
Registration Number
NCT00543387

Safety and Efficacy Study of of Docetaxel vs Docetaxel Estramustine in Hormone Refractory Prostatic Cancer

Phase 2
Completed
Conditions
Hormone Resistant Prostate Cancer
Metastatic Prostate Cancer
Interventions
First Posted Date
2007-10-10
Last Posted Date
2009-10-27
Lead Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Target Recruit Count
150
Registration Number
NCT00541281
Locations
🇧🇪

Parc Léopold, Brussels, Belgium

🇧🇪

Sint Nilolaus, Eupen, Belgium

🇧🇪

CH Jolimont Lobbes, La-Louvière, Belgium

and more 16 locations

Bevacizumab and Docetaxel in Treating Older Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Phase 2
Completed
Conditions
Lung Cancer
Interventions
Biological: bevacizumab
Drug: docetaxel
First Posted Date
2007-10-08
Last Posted Date
2019-03-27
Lead Sponsor
Barbara Ann Karmanos Cancer Institute
Target Recruit Count
11
Registration Number
NCT00541099
Locations
🇺🇸

Case Comprehensive Cancer Center, Cleveland, Ohio, United States

🇺🇸

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

🇺🇸

Nevada Cancer Institute, Las Vegas, Nevada, United States

BREAST-10: Three-weekly Versus Weekly First-line Chemotherapy for Metastatic or Locally Advanced Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2007-10-08
Last Posted Date
2016-01-14
Lead Sponsor
National Cancer Institute, Naples
Target Recruit Count
139
Registration Number
NCT00540800
Locations
🇮🇹

Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B, Napoli, Italy

🇮🇹

Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C, Napoli, Italy

🇮🇹

Ospedale S. Luca ASL SA 3, Vallo della Lucania, Italy

© Copyright 2025. All Rights Reserved by MedPath