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
-

Bevacizumab Plus Gemcitabine, Docetaxel, Melphalan, and Carboplatin in Ovarian Cancer Patients

Phase 2
Terminated
Conditions
Ovarian Cancer
Interventions
First Posted Date
2007-12-31
Last Posted Date
2013-05-21
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
13
Registration Number
NCT00583622
Locations
🇺🇸

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

Docetaxel and Immunotherapy Prior to Prostatectomy for High-Risk Prostate Cancer

Phase 2
Terminated
Conditions
Prostate Cancer
First Posted Date
2007-12-20
Last Posted Date
2011-01-20
Lead Sponsor
Benaroya Research Institute
Target Recruit Count
6
Registration Number
NCT00577356
Locations
🇺🇸

Virginia Mason Medical Center, Seattle, Washington, United States

A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Docetaxel in Patients With Inflammatory or Locally Advanced Breast Cancer.

Phase 2
Terminated
Conditions
Breast Cancer
Interventions
First Posted Date
2007-12-19
Last Posted Date
2014-08-11
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
23
Registration Number
NCT00576901

Docetaxel, Trabectedin, and G-CSF or Pegfilgrastim in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer

Phase 2
Completed
Conditions
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
First Posted Date
2007-12-07
Last Posted Date
2018-07-18
Lead Sponsor
Gynecologic Oncology Group
Target Recruit Count
71
Registration Number
NCT00569673
Locations
🇺🇸

St. John's Regional Health Center, Springfield, Missouri, United States

🇺🇸

Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

🇺🇸

Cleveland Clinic Cancer Center at Fairview Hospital, Cleveland, Ohio, United States

and more 34 locations

A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer

Phase 3
Completed
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2007-12-04
Last Posted Date
2019-12-13
Lead Sponsor
Genentech, Inc.
Target Recruit Count
808
Registration Number
NCT00567190
Locations
🇺🇸

UCLA, Los Angeles, California, United States

🇺🇸

LAC USC Medical Center, Los Angeles, California, United States

🇺🇸

St. Barnabas Cancer Center, Livingston, New Jersey, United States

and more 312 locations

Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents

Phase 2
Completed
Conditions
Nasopharyngeal Neoplasms
Carcinoma
Interventions
First Posted Date
2007-11-30
Last Posted Date
2015-07-30
Lead Sponsor
Sanofi
Target Recruit Count
75
Registration Number
NCT00565448
Locations
🇲🇦

Investigational Site Number 504003, Rabat, Morocco

🇵🇭

Investigational Site Number 608002, Quezon City, Philippines

🇧🇷

Investigational Site Number 076002, Rio De Janeiro, Brazil

and more 23 locations

Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian, Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Phase 3
Active, not recruiting
Conditions
Fallopian Tube Mucinous Adenocarcinoma
Ovarian Clear Cell Adenocarcinofibroma
Ovarian Serous Adenocarcinoma
Primary Peritoneal Undifferentiated Carcinoma
Undifferentiated Carcinoma
Clear Cell Adenocarcinoma
Fallopian Tube Clear Cell Adenocarcinoma
Ovarian Brenner Tumor
Ovarian Clear Cell Adenocarcinoma
Ovarian Transitional Cell Carcinoma
Interventions
Drug: Carboplatin
Biological: Bevacizumab
Drug: Docetaxel
Drug: Gemcitabine Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Other: Quality-of-Life Assessment
First Posted Date
2007-11-30
Last Posted Date
2024-12-10
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
1052
Registration Number
NCT00565851
Locations
🇺🇸

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

🇺🇸

Sanford Bismarck Medical Center, Bismarck, North Dakota, United States

🇺🇸

Sanford Broadway Medical Center, Fargo, North Dakota, United States

and more 709 locations

Phase I Study of Vorinostat in Combination With Docetaxel in Patients With Advanced and Relapsed Solid Malignancies.

Phase 1
Terminated
Conditions
Bladder Cancer
Non-Small-Cell Lung Carcinoma
Prostate Cancer
Urothelial Carcinoma
Interventions
First Posted Date
2007-11-29
Last Posted Date
2016-12-02
Lead Sponsor
University of Michigan Rogel Cancer Center
Target Recruit Count
12
Registration Number
NCT00565227
Locations
🇺🇸

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

FDG-Labeled PET Scan in Planning Chemotherapy in Treating Patients With Stage IIIB or IV Non-Small Cell Lung Cancer

Phase 2
Completed
Conditions
Malignant Pleural Effusion
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Interventions
Drug: carboplatin
Drug: docetaxel
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Procedure: computed tomography
Procedure: positron emission tomography
Radiation: fludeoxyglucose F 18
Other: imaging biomarker analysis
First Posted Date
2007-11-28
Last Posted Date
2017-02-10
Lead Sponsor
University of Washington
Target Recruit Count
55
Registration Number
NCT00564733
Locations
🇺🇸

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

🇺🇸

Harborview Medical Center, Seattle, Washington, United States

A Study of Avastin (Bevacizumab) and Sequential Chemotherapy in Patients With Primary HER2 Negative Operable Breast Cancer.

Phase 2
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2007-11-16
Last Posted Date
2014-11-10
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
72
Registration Number
NCT00559754
© Copyright 2025. All Rights Reserved by MedPath