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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

Overview

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

Research Report

Published: Jul 7, 2025

A Comprehensive Monograph on Docetaxel: From Molecular Mechanisms to Clinical Frontiers

Executive Summary

Docetaxel is a cornerstone antineoplastic agent of the taxane class, established as a critical component in the treatment of a broad spectrum of solid tumors. As a semi-synthetic analogue of paclitaxel, it exerts its potent cytotoxic effects through a primary mechanism of promoting microtubule assembly and inhibiting depolymerization, leading to cell cycle arrest and apoptosis. This fundamental action has translated into proven survival benefits across multiple malignancies, securing its regulatory approval for the treatment of breast cancer, non-small cell lung cancer (NSCLC), prostate cancer, gastric adenocarcinoma, and squamous cell carcinoma of the head and neck. In prostate cancer, its efficacy is further enhanced by a secondary mechanism involving the disruption of androgen receptor signaling.

The clinical utility of docetaxel is, however, intrinsically linked to a significant and predictable toxicity profile. Its use is defined by the management of a triad of dose-limiting toxicities: myelosuppression (primarily neutropenia), cumulative fluid retention, and peripheral neuropathy. Furthermore, its poor aqueous solubility necessitates formulation with agents like polysorbate 80, which contributes to a risk of hypersensitivity reactions. Consequently, the administration of docetaxel is inseparable from mandatory premedication protocols with corticosteroids, which are essential for mitigating these adverse effects and enabling the delivery of therapeutically effective doses.

Continue reading the full research report

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2008/07/14
Phase 1
Terminated
2008/07/10
Phase 2
Completed
2008/07/10
Phase 1
Completed
2008/07/08
Phase 1
Completed
2008/06/30
Phase 2
Active, not recruiting
2008/06/26
Phase 1
Completed
Hellenic Oncology Research Group
2008/06/26
Phase 2
Terminated
Hellenic Oncology Research Group
2008/06/26
Phase 3
Terminated
2008/06/25
Phase 1
Terminated
2008/06/23
Phase 1
Completed

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