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
-

Docetaxel and Flavopiridol in Treating Patients With Refractory Metastatic Pancreatic Cancer

Phase 2
Completed
Conditions
Recurrent Pancreatic Cancer
Stage IV Pancreatic Cancer
Adenocarcinoma of the Pancreas
Interventions
First Posted Date
2006-05-31
Last Posted Date
2014-05-28
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
10
Registration Number
NCT00331682
Locations
๐Ÿ‡บ๐Ÿ‡ธ

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

ELDA: Elderly Breast Cancer - Docetaxel in Adjuvant Treatment

Phase 3
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2006-05-29
Last Posted Date
2017-03-28
Lead Sponsor
National Cancer Institute, Naples
Target Recruit Count
300
Registration Number
NCT00331097
Locations
๐Ÿ‡ฎ๐Ÿ‡น

Azienda Ospedaliera G. Rummo, Benevento, BN, Italy

๐Ÿ‡ฎ๐Ÿ‡น

Policlinico Monteluce, Sant'Andrea delle Frate, PG, Italy

๐Ÿ‡ฎ๐Ÿ‡น

Universitร  Federico II, Cattedra di Oncologia Medica, Napoli, Italy

and more 5 locations

Safety Study of Imexon Plus Docetaxel in Lung, Breast or Prostate Cancer Patients

Phase 1
Completed
Conditions
Non-small Cell Lung Cancer
Breast Cancer
Prostate Cancer
Interventions
First Posted Date
2006-05-18
Last Posted Date
2015-06-24
Lead Sponsor
AmpliMed Corporation
Target Recruit Count
34
Registration Number
NCT00327288
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Investigational Site 008, Houston, Texas, United States

Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-small Cell Lung Cancer That Was Removed By Surgery

Phase 3
Active, not recruiting
Conditions
Stage IIIA Lung Non-Small Cell Cancer AJCC v7
Stage IB Lung Non-Small Cell Carcinoma AJCC v7
Stage IIB Lung Non-Small Cell Carcinoma AJCC v7
Stage IIA Lung Non-Small Cell Carcinoma AJCC v7
Interventions
First Posted Date
2006-05-11
Last Posted Date
2024-12-27
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
1501
Registration Number
NCT00324805
Locations
๐Ÿ‡บ๐Ÿ‡ธ

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

๐Ÿ‡บ๐Ÿ‡ธ

University of Arizona Cancer Center-Orange Grove Campus, Tucson, Arizona, United States

๐Ÿ‡บ๐Ÿ‡ธ

Banner University Medical Center - Tucson, Tucson, Arizona, United States

and more 1157 locations

Phase1b to Evaluate Safety of AMG706 in Combination With Paclitaxel or Docetaxel for Breast Cancer

Phase 1
Completed
Conditions
Locally Recurrent and Metastatic Breast Cancer
Interventions
First Posted Date
2006-05-05
Last Posted Date
2013-07-31
Lead Sponsor
Amgen
Target Recruit Count
46
Registration Number
NCT00322400

Carboplatin or Docetaxel in Treating Women With Metastatic Genetic Breast Cancer

Phase 2
Completed
Conditions
brca1 Mutation Carrier
brca2 Mutation Carrier
Breast Cancer
Hereditary Breast/Ovarian Cancer (brca1, brca2)
First Posted Date
2006-05-04
Last Posted Date
2013-08-26
Lead Sponsor
University College London Hospitals
Target Recruit Count
148
Registration Number
NCT00321633
Locations
๐Ÿ‡ฎ๐Ÿ‡ฑ

Naharia Hospital, Naharia, Israel

๐Ÿ‡ฌ๐Ÿ‡ง

Clatterbridge Centre for Oncology, Merseyside, England, United Kingdom

๐Ÿ‡ฌ๐Ÿ‡ง

UCL Cancer Institute, Hampstead, London, England, United Kingdom

and more 22 locations

Neoadjuvant Bevacizumab Plus Docetaxel in High Risk Patients With Prostate Cancer Undergoing Radical Prostatectomy

Phase 2
Completed
Conditions
Prostate Cancer
Adenocarcinoma of the Prostate
Interventions
First Posted Date
2006-05-04
Last Posted Date
2016-05-16
Lead Sponsor
Mary-Ellen Taplin, MD
Target Recruit Count
42
Registration Number
NCT00321646
Locations
๐Ÿ‡บ๐Ÿ‡ธ

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

๐Ÿ‡บ๐Ÿ‡ธ

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

๐Ÿ‡บ๐Ÿ‡ธ

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

Capecitabine, Docetaxel and Gemcitabine in Patients With Advanced Pancreas Cancer

Phase 1
Completed
Conditions
Pancreatic Cancer
Interventions
First Posted Date
2006-05-03
Last Posted Date
2016-06-27
Lead Sponsor
Tony Bekaii-Saab
Target Recruit Count
21
Registration Number
NCT00320749
Locations
๐Ÿ‡บ๐Ÿ‡ธ

The University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

๐Ÿ‡บ๐Ÿ‡ธ

Ohio State University, Columbus, Ohio, United States

Cisplatin and Docetaxel Plus Docetaxel and Radiotherapy With Amifostine for Squamous Cell Carcinoma of the Head and Neck

Phase 1
Completed
Conditions
Head Cancer
Head and Neck Cancer
Neck Cancer
Cancer of Head and Neck
Neck Neoplasms
Interventions
First Posted Date
2006-04-27
Last Posted Date
2019-02-05
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
48
Registration Number
NCT00318890
Locations
๐Ÿ‡บ๐Ÿ‡ธ

University of Alabama at Birmingham, Birmingham, Alabama, United States

Weekly Versus 3-Weekly Docetaxel Plus Cisplatin for Advanced NSCLC

Phase 2
Completed
Conditions
Advanced Non-Small Cell Lung Cancer
First Posted Date
2006-04-27
Last Posted Date
2008-03-12
Lead Sponsor
Gachon University Gil Medical Center
Target Recruit Count
78
Registration Number
NCT00319514
Locations
๐Ÿ‡ฐ๐Ÿ‡ท

Gachon University Gil Medical Center, Incheon, Korea, Republic of

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