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
-

Safety Study of an Antisense Product in Prostate, Ovarian, NSCL, Breast or Bladder Cancer

Phase 1
Completed
Conditions
Neoplasms
Interventions
Drug: OGX-427
Drug: Docetaxel
First Posted Date
2007-06-19
Last Posted Date
2016-01-18
Lead Sponsor
Achieve Life Sciences
Target Recruit Count
64
Registration Number
NCT00487786
Locations
🇨🇦

BC Cancer Agency, Vancouver, British Columbia, Canada

🇨🇦

Juravinski Cancer Center, Hamilton, Ontario, Canada

🇺🇸

Seattle Cancer Care Alliance, Seattle, Washington, United States

Imatinib Mesylate (Gleevec) and Docetaxel in Patients With Head and Neck Squamous Cell Cancer

Phase 2
Completed
Conditions
Head and Neck Cancer
Squamous Cell Cancer
Interventions
First Posted Date
2007-06-13
Last Posted Date
2012-08-07
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
7
Registration Number
NCT00485485
Locations
🇺🇸

U.T.M.D. Anderson Cancer Center, Houston, Texas, United States

Treatment of Larotaxel/Docetaxel, +/- Trastuzumab, After Anthracycline-cyclophosphamide in Breast Cancer Patients

Phase 2
Completed
Conditions
Breast Neoplasms
Interventions
First Posted Date
2007-06-13
Last Posted Date
2011-06-28
Lead Sponsor
Sanofi
Target Recruit Count
330
Registration Number
NCT00485979
Locations
🇺🇾

Sanofi-Aventis Administrative Office, Montevideo, Uruguay

Docetaxel in Treating Patients With Relapsed Prostate Cancer

Phase 2
Terminated
Conditions
Prostate Cancer
First Posted Date
2007-06-05
Last Posted Date
2017-04-28
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
3
Registration Number
NCT00482274
Locations
🇺🇸

University Cancer Center at University of Washington Medical Center, Seattle, Washington, United States

🇺🇸

OHSU Knight Cancer Institute, Portland, Oregon, United States

Radiation Therapy, Docetaxel, and Hormone Therapy in High-Risk Locally Advanced Metastasized Prostate Cancer

Phase 1
Completed
Conditions
Prostate Cancer
Interventions
Drug: bicalutamide
Drug: docetaxel
Drug: goserelin
Radiation: intensity-modulated radiation therapy
First Posted Date
2007-06-05
Last Posted Date
2023-11-24
Lead Sponsor
University of Nebraska
Target Recruit Count
9
Registration Number
NCT00482807
Locations
🇺🇸

University of Nebraska Medical Center, Omaha, Nebraska, United States

Lapatinib In Combination With Chemotherapy In Subjects With Relapsed Breast Cancer

Phase 2
Terminated
Conditions
Relapsed Breast Cancer
Neoplasms, Breast
Interventions
First Posted Date
2007-05-28
Last Posted Date
2012-06-05
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
9
Registration Number
NCT00479856
Locations
🇺🇸

GSK Investigational Site, Fairfax, Virginia, United States

Iressa and Taxotere Study in Patients With Metastatic Urothelial Cancer

Phase 2
Terminated
Conditions
Bladder Cancer
Interventions
First Posted Date
2007-05-25
Last Posted Date
2015-11-01
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
50
Registration Number
NCT00479089
Locations
🇺🇸

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

Randomized Customized Adjuvant Chemotherapy (GECP-SCAT)

Phase 3
Completed
Conditions
Non-small-cell Lung Cancer
Interventions
Drug: Docetaxel/Cisplatin control
Drug: Docetaxel
Drug: Gemcitabine/Cisplatin
Drug: Docetaxel/Cisplatin
First Posted Date
2007-05-25
Last Posted Date
2024-12-12
Lead Sponsor
Spanish Lung Cancer Group
Target Recruit Count
500
Registration Number
NCT00478699
Locations
🇪🇸

Hospital de Elche, Elche, Alicante, Spain

🇪🇸

Hospital Central de Asturias, Oviedo, Asturias, Spain

🇪🇸

Ico - H. Germans Trias I Pujol, Badalona, Barcelona, Spain

and more 44 locations

Iressa as Second Line Therapy in Advanced NSCLC-Asia

Phase 3
Completed
Conditions
NSCLC
Interventions
First Posted Date
2007-05-24
Last Posted Date
2012-06-06
Lead Sponsor
AstraZeneca
Target Recruit Count
163
Registration Number
NCT00478049
Locations
🇰🇷

Research Site, Suwon, Korea, Republic of

A Phase II Safety and Tolerability Study of Bevacizumab When Added to Single-agent Chemotherapy to Treat Patient With Breast Cancer Metastatic to Brain

First Posted Date
2007-05-22
Last Posted Date
2013-07-17
Lead Sponsor
Duke University
Target Recruit Count
16
Registration Number
NCT00476827
Locations
🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

🇺🇸

Palm Beach Cancer Center Institute, West Palm Beach, Florida, United States

🇺🇸

Presbyterian Health Care, Charlotte, North Carolina, United States

and more 1 locations
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