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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LDFWART With Docetaxel in Patients With Platinum-Resistant Recurrent Ovarian Carcinoma

Phase 1
Withdrawn
Conditions
Ovarian Cancer
Ovarian Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Ovarian Cancer
Interventions
Radiation: Low Dose Fractionated Whole Abdominal Radiation Therapy
Drug: Docetaxel
First Posted Date
2014-03-11
Last Posted Date
2016-08-10
Lead Sponsor
University of Miami
Registration Number
NCT02083536

Low-Tox Vs Eox In Patients With Locally Advanced Unresectable Or Metastatic Gastric Cancer

Phase 3
Terminated
Conditions
Locally Advanced Unresectable Gastric Cancer
Metastatic Gastric Cancer
Interventions
First Posted Date
2014-03-03
Last Posted Date
2019-10-09
Lead Sponsor
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Target Recruit Count
171
Registration Number
NCT02076594
Locations
🇮🇹

Ospedale L. Sacco, Milano, MI, Italy

🇮🇹

Osped. Di Circolo Serbelloni-Gorgonzola, Gorgonzola, MI, Italy

🇮🇹

Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, BG, Italy

and more 22 locations

The Optimal Intervention Time of Radiotherapy for Oligometastatic Stage IV Non-small Cell Lung Cancer(NSCLC)

Phase 3
Conditions
Oligo-metastatic Stage IV Non-small Cell Lung Cancer
Interventions
Radiation: concurrent chemoradiotherapy
Drug: Docetaxel
Drug: pemetrexed
Drug: Cisplatin
First Posted Date
2014-03-03
Last Posted Date
2020-03-17
Lead Sponsor
Sichuan Cancer Hospital and Research Institute
Target Recruit Count
420
Registration Number
NCT02076477
Locations
🇨🇳

Sichuan Cancer Hospital & Institute, Chengdu, Sichuan, China

SBRT With Cetuximab +/- Docetaxel Followed by Adjuvant Cetuximab +/- Docetaxel in Recurrent, Previously-Irradiated SCCHN

Phase 2
Completed
Conditions
Previously-Irradiated
Squamous Cell Carcinoma of the Head and Neck Cancer
Interventions
First Posted Date
2014-02-06
Last Posted Date
2023-06-05
Lead Sponsor
Heath Skinner
Target Recruit Count
40
Registration Number
NCT02057107
Locations
🇺🇸

UPMC Hillman Cancer Center - Radiation Oncology, Pittsburgh, Pennsylvania, United States

Assessing Tumor Response and IMRT Treat Plan After IC Based on FDG-PET/CT for Locally Advanced HNSCC

Phase 2
Completed
Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
Radiation: IMRT
Radiation: PET/CT
Drug: Docetaxel
Drug: Fluorouracil
Drug: Cisplatin
First Posted Date
2014-01-28
Last Posted Date
2016-03-02
Lead Sponsor
Lithuanian University of Health Sciences
Target Recruit Count
40
Registration Number
NCT02047201
Locations
🇱🇹

Lithuanian University of Health Sciences, Kaunas, Lithuania

Biweekly Docetaxel in Patients With Metastatic Breast Cancer.

Phase 2
Completed
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2014-01-22
Last Posted Date
2016-01-27
Lead Sponsor
Centro Universitario contra el Cáncer
Target Recruit Count
17
Registration Number
NCT02041351
Locations
🇲🇽

Jesus Livio Jimenez Santos, Monterrey, Nuevo León, Mexico

🇲🇽

Centro Universitario Contra El Cáncer, Monterrey, Nuevo León, Mexico

Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC

Phase 1
Conditions
Colorectal Cancer
Interventions
First Posted Date
2014-01-17
Last Posted Date
2018-08-27
Lead Sponsor
The Netherlands Cancer Institute
Target Recruit Count
35
Registration Number
NCT02039336
Locations
🇳🇱

Erasmus Medical Center Cancer Institute, Rotterdam, Netherlands

🇳🇱

The Netherlands Cancer Institute, Amsterdam, Netherlands

🇳🇱

University Medical Center Utrecht, Utrecht, Netherlands

Safety and Effectiveness Study of Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With NSCLC

Phase 2
Conditions
Non Small Cell Lung Cancer
Interventions
First Posted Date
2014-01-16
Last Posted Date
2016-02-23
Lead Sponsor
Fudan University
Target Recruit Count
80
Registration Number
NCT02037997
Locations
🇨🇳

Cancer hospital Fudan University, Shanghai, Shanghai, China

Erlotinib Monotherapy Versus Docetaxel and Cisplatin as Neoadjuvant Therapy in Patients of stageIIIA Lung ca

Phase 2
Conditions
Non-small Cell Lung Cancer(NSCLC)
Interventions
First Posted Date
2014-01-15
Last Posted Date
2014-01-15
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
76
Registration Number
NCT02036359
Locations
🇨🇳

Department of Oncology, National Taiwan University Hospital, Taipei,, Taiwan

Sorafenib Tosylate, Cisplatin, and Docetaxel in Treating Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Phase 1
Completed
Conditions
Recurrent Metastatic Squamous Neck Cancer With Occult Primary
Recurrent Salivary Gland Cancer
Recurrent Squamous Cell Carcinoma of the Hypopharynx
Stage IVA Salivary Gland Cancer
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IV Squamous Cell Carcinoma of the Hypopharynx
Stage IVA Oral Cavity Squamous Cell Carcinoma
Stage IVA Squamous Cell Carcinoma of the Oropharynx
Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Interventions
First Posted Date
2014-01-14
Last Posted Date
2018-05-24
Lead Sponsor
Ohio State University Comprehensive Cancer Center
Target Recruit Count
3
Registration Number
NCT02035527
Locations
🇺🇸

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

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