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
-

Docetaxel Plus Lycopene in Castration Resistant, Chemotherapy-Naïve Prostate Cancer Patients

Phase 2
Completed
Conditions
Recurrent Prostate Cancer
Adenocarcinoma of the Prostate
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer
Interventions
Drug: Docetaxel
Dietary Supplement: Lycopene
First Posted Date
2013-06-21
Last Posted Date
2021-01-05
Lead Sponsor
University of California, Irvine
Target Recruit Count
14
Registration Number
NCT01882985
Locations
🇺🇸

Chao Family Comprehensive Cancer Center, Orange, California, United States

Efficacy and Safety of Bevacizumab in the Neodjuvant Treatment of Inflammatory Breast Cancer

Phase 1
Conditions
Inflammatory Breast Cancer
Interventions
First Posted Date
2013-06-19
Last Posted Date
2013-06-19
Lead Sponsor
Association Tunisienne de lutte Contre le Cancer
Target Recruit Count
30
Registration Number
NCT01880385
Locations
🇹🇳

Institut Salah Azaiz, Bab Saadoun, Tunis, Tunisia

Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma

Phase 1
Completed
Conditions
Sarcoma
Interventions
First Posted Date
2013-06-17
Last Posted Date
2022-09-21
Lead Sponsor
Melissa Burgess, MD
Target Recruit Count
37
Registration Number
NCT01879085
Locations
🇺🇸

Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

A Study Evaluating The PF-03084014 In Combination With Docetaxel In Patients With Advanced Breast Cancer

Phase 1
Terminated
Conditions
Breast Cancer Metastatic
Interventions
Drug: PF-03084014
Drug: Docetaxel
First Posted Date
2013-06-12
Last Posted Date
2019-03-15
Lead Sponsor
Pfizer
Target Recruit Count
30
Registration Number
NCT01876251
Locations
🇮🇹

Instituto Europeo di Oncologia, Milano, Italy

🇺🇸

Karmanos Cancer Institute (KCI), Detroit, Michigan, United States

🇺🇸

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

and more 12 locations

Phase II Trial for Large ER-Negative Breast Cancers

Phase 2
Completed
Conditions
Malignant Neoplasm of Female Breast
Interventions
First Posted Date
2013-06-05
Last Posted Date
2019-09-24
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
72
Registration Number
NCT01869192
Locations
🇺🇸

University of Colorado Cancer Center, Aurora, Colorado, United States

Study to Evaluate GSK3052230 in Combination With Paclitaxel and Carboplatin, or Docetaxel or as Single Agent in Subjects With Solid Malignancies and Deregulated Fibroblast Growth Factor (FGF) Pathway Signaling

Phase 1
Completed
Conditions
Neoplasms
Interventions
First Posted Date
2013-06-04
Last Posted Date
2019-08-19
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
65
Registration Number
NCT01868022
Locations
🇬🇧

GSK Investigational Site, Nottingham, United Kingdom

A Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of GDC-0032 in Combination With Docetaxel or With Paclitaxel in Patients With HER2-negative Locally Recurrent or Metastatic Breast Cancer or Non-small Cell Lung Cancer

Phase 1
Completed
Conditions
Breast Cancer, Non-small Lung Cancer
Interventions
First Posted Date
2013-05-24
Last Posted Date
2017-11-28
Lead Sponsor
Genentech, Inc.
Target Recruit Count
80
Registration Number
NCT01862081
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Texas Oncology, P.A; Baylor Sammons Cancer Center, Dallas, Texas, United States

and more 11 locations

Dose Escalation, Multi-arm Study of MLN4924 Plus Docetaxel, Gemcitabine, or Combination of Carboplatin and Paclitaxel in Participants With Solid Tumors

Phase 1
Completed
Conditions
Solid Tumors
Interventions
First Posted Date
2013-05-24
Last Posted Date
2020-06-22
Lead Sponsor
Millennium Pharmaceuticals, Inc.
Target Recruit Count
64
Registration Number
NCT01862328

Phase I Study of LB-100 With Docetaxel in Solid Tumors

Phase 1
Completed
Conditions
Neoplasms
Tumors
Cancer
Interventions
First Posted Date
2013-04-23
Last Posted Date
2017-01-24
Lead Sponsor
Lixte Biotechnology Holdings, Inc.
Target Recruit Count
29
Registration Number
NCT01837667
Locations
🇺🇸

Texas Oncology - Tyler, Tyler, Texas, United States

🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

🇺🇸

Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States

and more 2 locations

A Study of Raltitrexed Plus Docetaxel Versus Docetaxel as Second-line Chemotherapy in Subjects With Gastric Cancer

Phase 2
Conditions
Gastric Cancer
Interventions
First Posted Date
2013-04-19
Last Posted Date
2013-04-19
Lead Sponsor
Hebei Tumor Hospital
Target Recruit Count
100
Registration Number
NCT01836120
Locations
🇨🇳

Hebei Tumor Hospital, Shijiazhuang, Hebei, China

© Copyright 2025. All Rights Reserved by MedPath