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
-

AEG35156 and Docetaxel in Treating Patients With Solid Tumors

Phase 1
Completed
Conditions
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
First Posted Date
2006-07-27
Last Posted Date
2023-08-04
Lead Sponsor
NCIC Clinical Trials Group
Target Recruit Count
10
Registration Number
NCT00357747
Locations
🇨🇦

BCCA - Vancouver Cancer Centre, Vancouver, British Columbia, Canada

🇨🇦

Univ. Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada

🇨🇦

McGill University - Dept. Oncology, Montreal, Quebec, Canada

Docetaxel & Oxaliplatin in Combination With Bevacizumab as First-Line Treatment in Subjects With Non-Small Cell Lung Cancer (NSCLC)

Phase 2
Completed
Conditions
Non-Small Cell Lung Cancer
Interventions
First Posted Date
2006-07-25
Last Posted Date
2011-10-17
Lead Sponsor
Sanofi
Target Recruit Count
53
Registration Number
NCT00356122
Locations
🇺🇸

Sanofi-Aventis Administrative Office, Bridgewater, New Jersey, United States

A Phase 2 Study Evaluating ABT-751 in Combination With Taxotere in Advanced Non-Small Cell Lung Cancer

Phase 1
Terminated
Conditions
Lung Cancer
Non-Small Cell Lung Cancer
Interventions
First Posted Date
2006-07-20
Last Posted Date
2011-01-07
Lead Sponsor
Abbott
Target Recruit Count
75
Registration Number
NCT00354562
Locations
🇺🇸

Site Ref # / Investigator 3571, Nashville, Tennessee, United States

🇮🇪

Site Ref # / Investigator 5097, Cork, Ireland

🇨🇦

Site Ref # / Investigator 3563, Sydney, Nova Scotia, Canada

and more 29 locations

Docetaxel and Capecitabine in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cavity Cancer

Phase 2
Terminated
Conditions
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Interventions
First Posted Date
2006-07-20
Last Posted Date
2017-08-30
Lead Sponsor
Wake Forest University Health Sciences
Target Recruit Count
2
Registration Number
NCT00354601
Locations
🇺🇸

Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States

Combination Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer

Phase 2
Terminated
Conditions
Head and Neck Cancer
Interventions
Biological: filgrastim
Biological: pegfilgrastim
Drug: cisplatin
Drug: docetaxel
Drug: fluorouracil
Procedure: conventional surgery
Radiation: radiation therapy
First Posted Date
2006-07-14
Last Posted Date
2017-12-28
Lead Sponsor
Masonic Cancer Center, University of Minnesota
Target Recruit Count
4
Registration Number
NCT00352118
Locations
🇺🇸

Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota, United States

Docetaxel, Radiation Therapy, and Prednisone in Treating Patients Who Have Undergone Surgery For Prostate Cancer

Phase 2
Terminated
Conditions
Prostate Cancer
Interventions
Drug: docetaxel
Drug: prednisone
Procedure: Radical prostatectomy
Radiation: Radiation therapy
First Posted Date
2006-07-06
Last Posted Date
2017-12-08
Lead Sponsor
The University of Texas Health Science Center at San Antonio
Target Recruit Count
21
Registration Number
NCT00348816
Locations
🇺🇸

University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States

The DISTAL-2 Study: Docetaxel Alone or in Combination in Second-line Treatment of Advanced Non Small-Cell Lung Cancer

Phase 3
Terminated
Conditions
Advanced Non-Small Cell Lung Cancer
Interventions
First Posted Date
2006-06-27
Last Posted Date
2016-01-14
Lead Sponsor
National Cancer Institute, Naples
Target Recruit Count
84
Registration Number
NCT00345059
Locations
🇮🇹

Ospedali Riuniti, Foggia, FG, Italy

🇮🇹

Ospedale Civile di Legnano, Legnano, MI, Italy

🇮🇹

Ospedale S. Paolo, Milano, MI, Italy

and more 21 locations

Docetaxel Followed by Surgery in Treating Women With Stage II or Stage III Breast Cancer

Phase 2
Terminated
Conditions
Breast Cancer
Interventions
Drug: docetaxel
Genetic: protein expression analysis
Other: laboratory biomarker analysis
Procedure: biopsy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
First Posted Date
2006-06-23
Last Posted Date
2012-04-27
Lead Sponsor
Vanderbilt-Ingram Cancer Center
Target Recruit Count
34
Registration Number
NCT00343512
Locations
🇺🇸

Meharry Medical College, Nashville, Tennessee, United States

🇺🇸

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

Docetaxel in Locally Advanced Gastric Adenocarcinoma

Phase 2
Completed
Conditions
Stomach Neoplasms
Interventions
First Posted Date
2006-06-22
Last Posted Date
2014-11-04
Lead Sponsor
Sanofi
Target Recruit Count
59
Registration Number
NCT00343239
Locations
🇹🇷

Sanofi-Aventis Administrative Office, Istanbul, Turkey

Combination Chemotherapy, Radiation Therapy, and Bevacizumab in Treating Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery

Phase 2
Active, not recruiting
Conditions
Lung Adenocarcinoma
Lung Large Cell Carcinoma
Lung Squamous Cell Carcinoma
Minimally Invasive Lung Adenocarcinoma
Stage IIIA Lung Non-Small Cell Cancer AJCC v7
Stage IIIB Lung Non-Small Cell Cancer AJCC v7
Lung Adenosquamous Carcinoma
Interventions
First Posted Date
2006-06-08
Last Posted Date
2024-12-27
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
29
Registration Number
NCT00334815
Locations
🇺🇸

Ballad Health Cancer Care - Norton, Norton, Virginia, United States

🇺🇸

Providence Hospital, Mobile, Alabama, United States

🇺🇸

Saint Bernards Regional Medical Center, Jonesboro, Arkansas, United States

and more 60 locations
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