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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A Phase I Study of Intraperitoneal Hyperthermic Docetaxel

Phase 1
Completed
Conditions
Ovarian Carcinoma
Interventions
First Posted Date
2007-05-17
Last Posted Date
2018-01-09
Lead Sponsor
University of Louisville
Target Recruit Count
30
Registration Number
NCT00474669
Locations
🇺🇸

James Graham Brown Cancer Center, Louisville, Kentucky, United States

OGX-011 and Docetaxel in Treating Patients With Metastatic or Locally Recurrent Solid Tumors

Phase 1
Completed
Conditions
Breast Cancer
Kidney Cancer
Bladder Cancer
Ovarian Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Lung Cancer
Prostate Cancer
First Posted Date
2007-05-10
Last Posted Date
2023-08-04
Lead Sponsor
NCIC Clinical Trials Group
Target Recruit Count
40
Registration Number
NCT00471432

A Study Of Docetaxel Or Docetaxel Plus PF-3512676 To Treat Patients With Advanced Breast Cancer.

Phase 2
Withdrawn
Conditions
Breast Neoplasms
First Posted Date
2007-05-09
Last Posted Date
2015-05-04
Lead Sponsor
Pfizer
Registration Number
NCT00471159

A Phase 2 Study With Enzastaurin Plus Chemotherapy or Placebo Plus Chemotherapy for Prostate Cancer Patients

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2007-04-27
Last Posted Date
2020-11-06
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
108
Registration Number
NCT00466440
Locations
🇮🇹

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., San Sisto, Italy

Therapy With Bevacizumab (BEV), Epirubicin, and Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and BEV Given as Neoadjuvant or Adjuvant Therapy for Women With Locally Advanced HER2 Positive Invasive Breast Cancer

First Posted Date
2007-04-23
Last Posted Date
2021-10-25
Lead Sponsor
NSABP Foundation Inc
Target Recruit Count
105
Registration Number
NCT00464646
Locations
🇺🇸

CCOP, Cancer Research for the Ozarks, Springfield, Missouri, United States

🇺🇸

Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

🇺🇸

University Hospital and Medical Center - SUNY, Stony Brook, New York, United States

and more 33 locations

MRI in Evaluating Early Response to Chemotherapy in Women Receiving Chemotherapy for Infiltrating Breast Cancer

Not Applicable
Completed
Conditions
Breast Cancer
First Posted Date
2007-04-19
Last Posted Date
2011-05-13
Lead Sponsor
Institut Bergonié
Target Recruit Count
30
Registration Number
NCT00462696
Locations
🇫🇷

Institut Bergonie, Bordeaux, France

Docetaxel + Doxorubicin as Neoadjuvant Chemotherapy in Patients With Breast Cancer

Phase 2
Terminated
Conditions
Ductal Carcinoma
First Posted Date
2007-04-18
Last Posted Date
2008-04-03
Lead Sponsor
Sanofi
Target Recruit Count
20
Registration Number
NCT00461344

PR-104 and Docetaxel or Gemcitabine in Treating Patients With Solid Tumors

Phase 1
Completed
Conditions
Unspecified Adult Solid Tumor, Protocol Specific
First Posted Date
2007-04-13
Last Posted Date
2011-03-02
Lead Sponsor
Proacta, Incorporated
Target Recruit Count
42
Registration Number
NCT00459836
Locations
🇳🇿

University of Auckland Cancer Center, Auckland, New Zealand

🇳🇿

Waikato Hospital, Hamilton, New Zealand

🇺🇸

Proacta, Incorporated, San Diego, California, United States

The Use of RAD001 With Docetaxel in the Treatment of Metastatic, Androgen Independent Prostate Cancer

Phase 1
Completed
Conditions
Metastatic, Androgen Independent Prostate Cancer
Prostate Cancer
Interventions
First Posted Date
2007-04-11
Last Posted Date
2016-05-16
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
19
Registration Number
NCT00459186
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

and more 2 locations

Docetaxel in Combination With Zactima (ZD6474) in Patients With Locally Advanced Squamous Cell Carcinoma of the the Head and Neck

Phase 2
Completed
Conditions
Squamous Cell Carcinoma of Head and Neck
Interventions
Drug: Docetaxel
Drug: ZD6474
First Posted Date
2007-04-11
Last Posted Date
2013-07-03
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
30
Registration Number
NCT00459043
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

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

🇺🇸

Loyola University Medical Center/Cardinal Bernadin Cancer Center, Maywood, Illinois, United States

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