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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
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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A Phase 1 Study of Alisertib Participants With Advanced Solid Tumors Including Castration-Resistant Prostate Cancer Receiving a Standard Docetaxel Regimen

Phase 1
Completed
Conditions
Advanced Solid Tumors
Adenocarcinoma of the Prostate
Interventions
First Posted Date
2010-03-26
Last Posted Date
2019-02-15
Lead Sponsor
Millennium Pharmaceuticals, Inc.
Target Recruit Count
41
Registration Number
NCT01094288

A Study of Bevacizumab With Taxane Therapy in Participants With Triple Negative Breast Cancer

Phase 4
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2010-03-26
Last Posted Date
2018-03-22
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
49
Registration Number
NCT01094184

Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Nonmetastatic Breast Cancer

Phase 3
Conditions
Breast Cancer
Cardiac Toxicity
Perioperative/Postoperative Complications
First Posted Date
2010-03-25
Last Posted Date
2010-03-25
Lead Sponsor
Cambridge University Hospitals NHS Foundation Trust
Target Recruit Count
800
Registration Number
NCT01093235
Locations
🇬🇧

Addenbrooke's Hospital, Cambridge, England, United Kingdom

Study of TAK-700 in Combination With Docetaxel and Prednisone in Men With Metastatic Castration-Resistant Prostate Cancer

Phase 1
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2010-03-10
Last Posted Date
2019-07-30
Lead Sponsor
Millennium Pharmaceuticals, Inc.
Target Recruit Count
38
Registration Number
NCT01084655
Locations
🇺🇸

Alaska Clinical Research Center, LLC, Anchorage, Alaska, United States

Phase II Trial of AUY922 vs. Comparators in Advanced Gastric Cancer

Phase 2
Completed
Conditions
Advanced Gastric Cancer
Gastro-esophageal Junction Cancer
Interventions
First Posted Date
2010-03-10
Last Posted Date
2020-12-10
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
68
Registration Number
NCT01084330
Locations
🇺🇸

University of California at Los Angeles Dept. of UCLA (4), Los Angeles, California, United States

🇺🇸

Horizon Oncology Center, Lafayette, Indiana, United States

🇺🇸

Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology, Dallas, Texas, United States

and more 5 locations

Imatinib Mesylate and Docetaxel in Non-Small Cell Lung Cancer (NSCLC)

Phase 2
Completed
Conditions
Non-small Cell Lung Cancer
Interventions
First Posted Date
2010-03-10
Last Posted Date
2012-01-11
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
22
Registration Number
NCT01083589
Locations
🇺🇸

UT MD Anderson Cancer Center, Houston, Texas, United States

A Study Evaluating the Pain Palliation Benefit of Adding Custirsen to Docetaxel Retreatment or Cabazitaxel as Second Line Therapy in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Phase 3
Terminated
Conditions
Hormone Refractory Prostate Cancer
Castrate-Resistant Prostate Cancer
Interventions
First Posted Date
2010-03-10
Last Posted Date
2016-10-12
Lead Sponsor
Achieve Life Sciences
Target Recruit Count
14
Registration Number
NCT01083615

Neoadjuvant Hormones + Docetaxel in Node-Positive Prostate Cancer

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
Drug: Neoadjuvant Hormonal Therapy
Drug: Docetaxel
First Posted Date
2010-02-26
Last Posted Date
2016-09-19
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
40
Registration Number
NCT01076335
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Second-Line Docetaxel + ASA404 for Advanced Urothelial Carcinoma

Phase 2
Withdrawn
Conditions
Urothelial Carcinoma
Interventions
Drug: Docetaxel
Drug: ASA404
First Posted Date
2010-02-19
Last Posted Date
2015-08-19
Lead Sponsor
Hoosier Cancer Research Network
Registration Number
NCT01071928

Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck

Phase 2
Completed
Conditions
Recurrent Hypopharyngeal Squamous Cell Carcinoma
Recurrent Oral Cavity Squamous Cell Carcinoma
Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7
Stage IVA Hypopharyngeal Squamous Cell Carcinoma AJCC v7
Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7
Stage IVB Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
Metastatic Squamous Cell Carcinoma of the Oropharynx
Stage IVB Hypopharyngeal Squamous Cell Carcinoma AJCC v7
Stage IVC Laryngeal Squamous Cell Carcinoma AJCC v7
Metastatic Squamous Cell Carcinoma of the Hypopharynx
Interventions
Drug: Carboplatin
Drug: Cisplatin
Drug: Docetaxel
Drug: Erlotinib Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Placebo
Other: Pharmacological Study
Other: Quality-of-Life Assessment
First Posted Date
2010-02-08
Last Posted Date
2024-07-16
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
123
Registration Number
NCT01064479
Locations
🇺🇸

MD Anderson Regional Care Center-Bay Area, Nassau Bay, Texas, United States

🇺🇸

MD Anderson Regional Care Center-Sugar Land, Sugar Land, Texas, United States

🇺🇸

MD Anderson Regional Care Center-The Woodlands, The Woodlands, Texas, United States

and more 2 locations
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