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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Intercalated Combination of Chemotherapy and Tyrosine Kinase Inhibitors as First-line Treatment for Patients With Non-Small-Cell Lung Cancer

First Posted Date
2014-01-09
Last Posted Date
2016-03-29
Lead Sponsor
Qilu Hospital of Shandong University
Target Recruit Count
250
Registration Number
NCT02031601
Locations
🇨🇳

Yu Li, Jinan, Shandong, China

Study of LDE225 (Sonidegib) in Combination With Docetaxel in Triple Negative (TN) Advanced Breast Cancer (ABC) Patients

Phase 1
Completed
Conditions
Advanced Breast Cancer
Interventions
First Posted Date
2014-01-06
Last Posted Date
2023-04-03
Lead Sponsor
Spanish Breast Cancer Research Group
Target Recruit Count
12
Registration Number
NCT02027376
Locations
🇪🇸

Complejo Hospitalario Universitario A Coruña, A Coruña, Spain

🇪🇸

Hospital General Universitario Gregorio Marañón, Madrid, Spain

🇪🇸

Hospital Clínico Universitario San Carlos, Madrid, Spain

and more 2 locations

A Phase II Study of Docetaxel and Carboplatin in Late Relapse of Ovarian Cancer

Phase 2
Completed
Conditions
Ovarian Epithelial Cancer Recurrent
Interventions
First Posted Date
2014-01-03
Last Posted Date
2014-01-03
Lead Sponsor
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Target Recruit Count
74
Registration Number
NCT02026921
Locations
🇫🇮

Tampere University Hospital, Tampere, Finland

🇳🇴

Norwegian Radium Hospital, Oslo, Norway

🇩🇰

Herlev University Hospital, Copenhagen, Denmark

and more 1 locations

A Study of Pertuzumab and Trastuzumab Subcutaneous (SC) Treatment in Combination With a Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer

First Posted Date
2013-12-24
Last Posted Date
2018-09-13
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
50
Registration Number
NCT02019277
Locations
🇦🇺

Fiona Stanley Hospital, Murdoch, Western Australia, Australia

🇦🇺

St George Hospital; Cancer Care Centre, Kogarah, New South Wales, Australia

🇦🇺

Port Macquarie Base Hospital, Port Macquarie, New South Wales, Australia

and more 10 locations

A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy

Phase 3
Completed
Conditions
Non-Squamous Non-Small Cell Lung Cancer
Interventions
First Posted Date
2013-12-11
Last Posted Date
2019-12-20
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
1225
Registration Number
NCT02008227
Locations
🇺🇸

Comprehensive Blood/Cancer Ctr, Bakersfield, California, United States

🇺🇸

Roy & Patricia Disney Family Cancer Center, Burbank, California, United States

🇺🇸

St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr, Fullerton, California, United States

and more 205 locations

MetronomIc CApecitabine and DOcetaxel as Second-line Chemotherapy for Advanced Gastric Cancer

Phase 2
Conditions
Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Interventions
First Posted Date
2013-12-10
Last Posted Date
2019-02-27
Lead Sponsor
International Group of Endovascular Oncology
Target Recruit Count
51
Registration Number
NCT02007148
Locations
🇮🇹

AORMN, Presidio Ospedaliero San Salvatore, Pesaro, Italy

🇮🇹

Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore, Pesaro, Italy

Study of Danggui Buxue Decoction in Preventing Neutropenia

Phase 2
Completed
Conditions
Grade 3/4 Neutropenia
Febrile Neutropenia
Interventions
First Posted Date
2013-12-09
Last Posted Date
2015-12-30
Lead Sponsor
Shanghai Jiao Tong University School of Medicine
Target Recruit Count
50
Registration Number
NCT02005783
Locations
🇨🇳

Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, China

Trastuzumab Plus Docetaxel and Capecitabine For First Line Treatment of Her2-Positive Advanced Gastric Cancer

Phase 2
Completed
Conditions
Stomach Neoplasms
Neoplasms Metastasis
ERBB2 Gene Amplification
Interventions
First Posted Date
2013-12-09
Last Posted Date
2016-11-18
Lead Sponsor
Sun Yat-sen University
Target Recruit Count
67
Registration Number
NCT02004769
Locations
🇨🇳

Medical Oncology,Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Primary Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2013-12-09
Last Posted Date
2014-07-14
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
18
Registration Number
NCT02005549

Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer

Phase 3
Active, not recruiting
Conditions
HER2-Positive Breast Carcinoma
Stage IIB Breast Cancer AJCC v6 and v7
Stage IIIB Breast Cancer AJCC v7
Stage IIIC Breast Cancer AJCC v7
Hormone Receptor-Positive Breast Carcinoma
Stage IIIA Breast Cancer AJCC v7
Stage IB Breast Cancer AJCC v7
Stage IIA Breast Cancer AJCC v6 and v7
Interventions
Drug: Aromatase Inhibition Therapy
Drug: Carboplatin
Other: Cytology Specimen Collection Procedure
Drug: Docetaxel
Drug: Goserelin Acetate
Biological: Pertuzumab
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Radiation: Whole Breast Irradiation
Procedure: Therapeutic Conventional Surgery
Biological: Trastuzumab
First Posted Date
2013-12-06
Last Posted Date
2024-11-13
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
315
Registration Number
NCT02003209
Locations
🇺🇸

Ochsner Medical Center Kenner, Kenner, Louisiana, United States

🇺🇸

Lafayette Family Cancer Center-EMMC, Brewer, Maine, United States

🇺🇸

Allegiance Health, Jackson, Michigan, United States

and more 728 locations
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