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
-

AZD6244 in Combination With Docetaxel Versus Docetaxel Alone in KRAS Mutation Positive NSCLC Patients

Phase 2
Completed
Conditions
Non Small Cell Lung Cancer
Interventions
First Posted Date
2009-04-30
Last Posted Date
2018-06-20
Lead Sponsor
AstraZeneca
Target Recruit Count
88
Registration Number
NCT00890825
Locations
🇪🇸

Research Site, Málaga, Spain

Safety Profile, MTD, and PK Profile Studies of ABT-263 When Administered in Combination With Standard and Weekly Regimens of Docetaxel in Subjects With Cancer

Phase 1
Completed
Conditions
Solid Tumor
Interventions
Drug: ABT-263
Drug: Docetaxel
First Posted Date
2009-04-24
Last Posted Date
2012-05-22
Lead Sponsor
Abbott
Target Recruit Count
41
Registration Number
NCT00888108
Locations
🇺🇸

Site Reference ID/Investigator# 43962, Baltimore, Maryland, United States

🇺🇸

Site Reference ID/Investigator# 51982, Scottsdale, Arizona, United States

🇳🇱

Site Reference ID/Investigator# 20042, Rotterdam, Netherlands

and more 3 locations

A Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer

First Posted Date
2009-04-24
Last Posted Date
2022-04-20
Lead Sponsor
NSABP Foundation Inc
Target Recruit Count
1613
Registration Number
NCT00887536
Locations
🇺🇸

Swedish Medical Center, Englewood, Colorado, United States

🇺🇸

University of Connecticut, Farmington, Connecticut, United States

🇺🇸

Texas Oncology Seton Williamson, Round Rock, Texas, United States

and more 494 locations

Gemcitabine and Docetaxel With Bevacizumab in Selected Sarcoma Subtypes

Phase 2
Completed
Conditions
Sarcoma
Leiomyosarcoma
Malignant Fibrous
Histiocytoma
Angiosarcoma
Interventions
First Posted Date
2009-04-24
Last Posted Date
2016-01-25
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
47
Registration Number
NCT00887809
Locations
🇺🇸

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

Individualized Treatment Based on Epidermal Growth Factor Receptor Mutations and Level of BRCA1 Expression in Advanced Adenocarcinoma

Not Applicable
Completed
Conditions
Non-small Cell Lung Cancer
Interventions
First Posted Date
2009-04-17
Last Posted Date
2022-06-13
Lead Sponsor
Spanish Lung Cancer Group
Target Recruit Count
153
Registration Number
NCT00883480
Locations
🇪🇸

Ico-Hospital Universitarios Germans Trias I Pujol, Badalona, Barcelona, Spain

🇪🇸

Hospital Carlos Haya, Málaga, Spain

A Study of Gemzar, Taxotere, and Xeloda for Adjuvant Pancreatic Cancer

Phase 2
Completed
Conditions
Pancreatic Cancer
Interventions
First Posted Date
2009-04-16
Last Posted Date
2016-07-25
Lead Sponsor
Columbia University
Target Recruit Count
37
Registration Number
NCT00882310

Randomized Study of Docetaxel +/- Vandetanib in Metastatic TCC

Phase 2
Completed
Conditions
Bladder Cancer
Transitional Cell Carcinoma
Interventions
First Posted Date
2009-04-13
Last Posted Date
2018-09-18
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
149
Registration Number
NCT00880334
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

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

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Taxotere/Prednisone Plus Sunitinib in Chemotherapy-Naïve, Hormone Refractory Prostate Cancer Patients

Phase 1
Terminated
Conditions
Stage IV Prostate Cancer
Prostate Cancer
Stage III Prostate Cancer
Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage I Prostate Cancer
Interventions
First Posted Date
2009-04-10
Last Posted Date
2017-02-01
Lead Sponsor
John P. Fruehauf
Target Recruit Count
4
Registration Number
NCT00879619
Locations
🇺🇸

Chao Comprehensive Cancer Center, Orange, California, United States

S0904: Docetaxel With or Without Vandetanib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Phase 2
Completed
Conditions
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Interventions
First Posted Date
2009-04-01
Last Posted Date
2016-12-19
Lead Sponsor
SWOG Cancer Research Network
Target Recruit Count
129
Registration Number
NCT00872989
Locations
🇺🇸

Sletten Cancer Institute at Benefis Healthcare, Great Falls, Montana, United States

🇺🇸

Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana, United States

🇺🇸

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana, United States

and more 134 locations

Radiation Therapy and Docetaxel Followed by Standard Therapy in Treating Women With Breast Cancer

Phase 1
Completed
Conditions
Breast Cancer
Interventions
Drug: cyclophosphamide
Drug: docetaxel
Drug: epirubicin hydrochloride
Drug: fluorouracil
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
Radiation: hypofractionated radiation therapy
Radiation: image-guided radiation therapy
Radiation: radiation therapy
Radiation: stereotactic radiosurgery
First Posted Date
2009-03-31
Last Posted Date
2015-02-10
Lead Sponsor
Centre Antoine Lacassagne
Target Recruit Count
26
Registration Number
NCT00872625
Locations
🇫🇷

Centre Antoine Lacassagne, Nice, France

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