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
-

Carboplatin Plus Docetaxel (Taxotere) in Anaplastic Prostate Cancer

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2007-08-10
Last Posted Date
2020-09-01
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
121
Registration Number
NCT00514540
Locations
🇺🇸

University of California-San Francisco, San Francisco, California, United States

🇺🇸

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

A Study of Androgen Deprivation With Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Participants With a Rising Prostate Specific Antigen (PSA)

Phase 3
Terminated
Conditions
Prostatic Neoplasms
Interventions
First Posted Date
2007-08-10
Last Posted Date
2013-11-03
Lead Sponsor
Sanofi
Target Recruit Count
413
Registration Number
NCT00514917
Locations
🇪🇸

Sanofi-Aventis Administrative Office, Barcelona, Spain

Bexarotene, Tretinoin, and Combination Chemotherapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Phase 2
Conditions
Lung Cancer
First Posted Date
2007-08-09
Last Posted Date
2014-01-10
Lead Sponsor
Raghu Nandan, M.D., Inc
Target Recruit Count
39
Registration Number
NCT00514293
Locations
🇺🇸

R. Nandan M.D. Incorporated, Lakewood, California, United States

An Open-Label Study of YM155 + Docetaxel in Subjects With Advanced Hormone Refractory Prostate Cancer and Other Solid Tumors

Phase 1
Completed
Conditions
Prostate Cancer
Tumors
Interventions
First Posted Date
2007-08-09
Last Posted Date
2015-08-13
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
32
Registration Number
NCT00514267

Panitumumab Chemoradiotherapy Chemotherapy for Squamous Cancer of the Head and Neck

Phase 1
Completed
Conditions
Squamous Cell Carcinoma of the Head and Neck
Interventions
First Posted Date
2007-08-08
Last Posted Date
2017-03-01
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
34
Registration Number
NCT00513383
Locations
🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Docetaxel, Cisplatin (TP) + Radiation +/- Cetuximab in Larynx Carcinoma (CA)

Phase 2
Completed
Conditions
Squamous Cell Carcinoma of the Hypopharynx
Larynx Carcinoma
Interventions
First Posted Date
2007-07-30
Last Posted Date
2015-06-02
Lead Sponsor
ClinAssess
Target Recruit Count
180
Registration Number
NCT00508664
Locations
🇦🇹

Universitätsklinik für HNO, Graz, Austria

🇦🇹

Allgemeines Krankenhaus der Stadt Wien, Vienna, Austria

🇦🇹

Landeskrankenhaus Klagenfurt, Klagenfurt, Austria

and more 24 locations

Avastin in Combination With Docetaxel in Ovarian/Fallopian Tube/Peritoneum Carcinoma

Phase 2
Completed
Conditions
Malignant Tumor of Peritoneum
Fallopian Tube Cancer
Ovarian Cancer
Interventions
First Posted Date
2007-07-19
Last Posted Date
2014-02-06
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
45
Registration Number
NCT00504257
Locations
🇺🇸

Broward General Medical Center Cancer Center, Fort Lauderdale, Florida, United States

🇺🇸

Women's Cancer Associates, Saint Petersburg, Florida, United States

🇺🇸

Duke Cancer Institute, Durham, North Carolina, United States

and more 1 locations

A Phase I/II Study of Azacitidine, Docetaxel, and Prednisone for Metastatic Prostate Cancer Patients

Phase 1
Terminated
Conditions
Prostate Cancer
Pain
Interventions
First Posted Date
2007-07-19
Last Posted Date
2016-06-09
Lead Sponsor
University of Miami
Target Recruit Count
22
Registration Number
NCT00503984
Locations
🇺🇸

University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, United States

A Study to Assess Safety, Tolerability and PK of AZD2171 and Chemotherapy on Patients With Solid Tumors

Phase 1
Completed
Conditions
Advanced Solid Tumor
First Posted Date
2007-07-17
Last Posted Date
2011-07-27
Lead Sponsor
AstraZeneca
Target Recruit Count
104
Registration Number
NCT00502567
Locations
🇺🇸

Research Site, Nashville, Tennessee, United States

Induction Chemotherapy Prior to Radio-immunotherapy in Head and Neck Cancer Stage III/IV - a Methodical Trial

Not Applicable
Completed
Conditions
Head and Neck Cancer
Interventions
First Posted Date
2007-07-17
Last Posted Date
2024-02-07
Lead Sponsor
Austrian South Oncology Group
Target Recruit Count
51
Registration Number
NCT00502463
Locations
🇦🇹

LKH Feldkirch, Dept. of Radiooncology, Feldkirch, Austria

🇦🇹

Medical University of Graz, Dept. of Radiooncology, Graz, Austria

🇦🇹

LKH Leoben Dept. of Hemato-Oncology, Leoben, Austria

and more 2 locations
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