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, Oxaliplatin, and Fluorouracil in Treating Patients With Metastatic or Unresectable Stomach Cancer, Gastroesophageal Junction Cancer, or Other Solid Tumor

Phase 1
Completed
Conditions
Gastric Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
First Posted Date
2008-07-08
Last Posted Date
2019-02-26
Lead Sponsor
Northwestern University
Target Recruit Count
59
Registration Number
NCT00711243
Locations
🇺🇸

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

Docetaxel, Cisplatin and Fluorouracil in Treating Patients with Previously Untreated Stage II-IV Nasal Cavity and Paranasal Sinus Cancer

Phase 2
Active, not recruiting
Conditions
Locally Advanced Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma
Nasal Cavity and Paranasal Sinus Poorly Differentiated Carcinoma
Sinonasal Undifferentiated Carcinoma
Stage II Nasal Cavity and Paranasal Sinus Cancer AJCC V8
Stage III Nasal Cavity and Paranasal Sinus Cancer AJCC V8
Stage IVA Nasal Cavity and Paranasal Sinus Cancer AJCC V8
Stage IVB Nasal Cavity and Paranasal Sinus Cancer AJCC V8
Interventions
Drug: Carboplatin
Other: Chemoradiotherapy
Drug: Cisplatin
Procedure: Definitive Surgical Resection
Drug: Docetaxel
Drug: Fluorouracil
Procedure: Quality-of-Life Assessment
Radiation: Radiation Therapy
First Posted Date
2008-06-30
Last Posted Date
2024-12-04
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
31
Registration Number
NCT00707473
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Docetaxel/Epirubicin/Bevacizumab as First Line Therapy for Metastatic HER2 Negative Breast Cancer

Phase 1
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2008-06-26
Last Posted Date
2010-08-19
Lead Sponsor
Hellenic Oncology Research Group
Target Recruit Count
46
Registration Number
NCT00705315
Locations
🇬🇷

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine, Athens, Greece

🇬🇷

State General Hospital of Larissa, Dep of Medical Oncology, Larissa,, Greece

🇬🇷

"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology, Athens, Greece

and more 7 locations

Individualized Therapy Based of Tumoral mRNA Levels of ERCC1, RRM1 and BRCA1 in Advanced Non-Small-Cell Lung Cancer

Phase 2
Terminated
Conditions
Non-Small-Cell Lung Cancer
Interventions
First Posted Date
2008-06-26
Last Posted Date
2013-02-13
Lead Sponsor
Hellenic Oncology Research Group
Target Recruit Count
88
Registration Number
NCT00705549
Locations
🇬🇷

Sotiria" General Hospital, 1st, 3rd, 8th Dep of Pulmonary Diseases, Athens, Greece

🇬🇷

"Metaxa's" Anticancer Hospital of Piraeus,1st Dep of Medical Oncology, Piraeus, Greece

🇬🇷

"Theagenion" Anticancer Hospital of Thessaloniki, Thessaloniki, Greece

and more 6 locations

PTC299 for Treatment of Advanced Cancer

Phase 1
Terminated
Conditions
Advanced Cancer
Interventions
First Posted Date
2008-06-25
Last Posted Date
2019-05-10
Lead Sponsor
PTC Therapeutics
Target Recruit Count
76
Registration Number
NCT00704821
Locations
🇺🇸

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Phase I Study of Docetaxel and Temsirolimus in Resistant Solid Malignancies

Phase 1
Completed
Conditions
Resistant Solid Malignancies
Interventions
First Posted Date
2008-06-23
Last Posted Date
2017-03-07
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
26
Registration Number
NCT00703625
Locations
🇺🇸

Washington University School of Medicine, St. Louis, Missouri, United States

Phase III Study of Docetaxel + Ramucirumab or Placebo in Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
Interventions
Biological: ramucirumab (IMC-1121B)
Other: Placebo
Drug: docetaxel
First Posted Date
2008-06-23
Last Posted Date
2021-12-06
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
1144
Registration Number
NCT00703326
Locations
🇬🇧

ImClone Investigational Site, Nottingham, United Kingdom

Effect of Ketoconazole Inhibition of CYP3A on Urinary Excretion of Docetaxel

Phase 2
Completed
Conditions
Solid Tumors
Interventions
First Posted Date
2008-06-13
Last Posted Date
2013-12-10
Lead Sponsor
National University Hospital, Singapore
Target Recruit Count
10
Registration Number
NCT00697437
Locations
🇸🇬

National University Hospital, Singapore, Singapore

The Effect of Docetaxel or Gemcitabine-based Chemotherapy in East Asian and Caucasian Patients

Phase 2
Completed
Conditions
Non Small Cell Lung Cancer
Breast Cancer
Interventions
First Posted Date
2008-06-12
Last Posted Date
2012-11-01
Lead Sponsor
National University Hospital, Singapore
Target Recruit Count
300
Registration Number
NCT00695994
Locations
🇸🇬

National University Hospital, Singapore, Singapore

Docetaxel Plus Oxaliplatin as Therapy in Patients With Pancreatic Cancer

Phase 2
Conditions
Pancreas Neoplasms
First Posted Date
2008-06-04
Last Posted Date
2010-03-03
Lead Sponsor
University of Ulm
Target Recruit Count
44
Registration Number
NCT00690300
Locations
🇩🇪

Universitätsklinikum Giessen und Marburg GmbH, Marburg, Hessen, Germany

🇩🇪

Klinikum Schwäbisch Gmünd, Mutlangen, Baden Württemberg, Germany

🇩🇪

Städtische Kliniken Esslingen, Esslingen, Baden Württemberg, Germany

and more 2 locations
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