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

Polyglutamate Paclitaxel Compared With Docetaxel in Treating Patients With Progressive Non-Small Cell Lung Cancer

Phase 3
Terminated
Conditions
Lung Cancer
Interventions
First Posted Date
2003-02-06
Last Posted Date
2020-10-05
Lead Sponsor
CTI BioPharma
Target Recruit Count
350
Registration Number
NCT00054184
Locations
🇺🇸

Saint Joseph Oncology, Incorporated, Saint Joseph, Missouri, United States

🇺🇸

Gabrail Cancer Center - Canton Office, Canton, Ohio, United States

🇺🇸

Montana Cancer Specialists, Missoula, Montana, United States

and more 30 locations

Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2003-02-06
Last Posted Date
2013-07-19
Lead Sponsor
UNICANCER
Target Recruit Count
3010
Registration Number
NCT00054587
Locations
🇫🇷

Centre Hospitalier de Mulhouse, Mulhouse, France

🇫🇷

Institut Prive de Cancerologie, Grenoble, France

🇫🇷

Centre Paul Papin, Angers, France

and more 26 locations

Combination Chemotherapy Compared With Observation After Surgery in Treating Women With Relapsed Nonmetastatic Breast Cancer

Phase 3
Terminated
Conditions
Breast Cancer
First Posted Date
2003-02-06
Last Posted Date
2014-12-16
Lead Sponsor
UNICANCER
Registration Number
NCT00053911
Locations
🇫🇷

Clinique Claude Bernard, Albi, France

🇫🇷

Institut Bergonie, Bordeaux, France

🇫🇷

Centre Paul Papin, Angers, France

and more 23 locations

Docetaxel and Capecitabine in Treating Patients With Metastatic Cancer of the Stomach or Gastroesophageal Junction

Phase 2
Completed
Conditions
Esophageal Cancer
Gastric Cancer
Interventions
First Posted Date
2003-02-06
Last Posted Date
2016-12-13
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
46
Registration Number
NCT00054457
Locations
🇺🇸

Associates in Womens Health, PA - North Review, Wichita, Kansas, United States

🇺🇸

Cancer Center of Kansas, PA - Wellington, Wellington, Kansas, United States

🇺🇸

Cancer Center of Kansas, PA - Winfield, Winfield, Kansas, United States

and more 25 locations

Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2003-02-06
Last Posted Date
2016-02-17
Lead Sponsor
Paula Silverman, MD
Target Recruit Count
39
Registration Number
NCT00054275
Locations
🇺🇸

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer

Phase 1
Completed
Conditions
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
Stage III Squamous Cell Carcinoma of the Hypopharynx
Stage III Squamous Cell Carcinoma of the Larynx
Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage III Squamous Cell Carcinoma of the Nasopharynx
Stage III Squamous Cell Carcinoma of the Oropharynx
Stage III Verrucous Carcinoma of the Larynx
Stage III Verrucous Carcinoma of the Oral Cavity
Stage IV Squamous Cell Carcinoma of the Hypopharynx
Stage IV Squamous Cell Carcinoma of the Nasopharynx
Interventions
Radiation: radiation therapy
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
Other: pharmacological study
First Posted Date
2003-01-27
Last Posted Date
2014-06-06
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
30
Registration Number
NCT00049283
Locations
🇺🇸

Case Western Reserve University, Cleveland, Ohio, United States

Vaccine Therapy With or Without Docetaxel in Treating Patients With Metastatic Prostate Cancer

Phase 2
Completed
Conditions
Prostate Cancer
First Posted Date
2003-01-27
Last Posted Date
2013-06-19
Lead Sponsor
National Cancer Institute (NCI)
Registration Number
NCT00045227
Locations
🇺🇸

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland, United States

Hormone Therapy Plus Chemotherapy in Treating Patients With Prostate Cancer

First Posted Date
2003-01-27
Last Posted Date
2020-10-22
Lead Sponsor
Radiation Therapy Oncology Group
Target Recruit Count
21
Registration Number
NCT00030654
Locations
🇺🇸

Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, United States

🇺🇸

Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado, United States

🇺🇸

Hope Cancer Care Center at Longmont United Hospital, Longmont, Colorado, United States

and more 75 locations

S9916, Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy

Phase 3
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2003-01-27
Last Posted Date
2014-02-25
Lead Sponsor
SWOG Cancer Research Network
Target Recruit Count
770
Registration Number
NCT00004001
Locations
🇺🇸

CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, United States

🇺🇸

Mayo Clinic, Jacksonville, Florida, United States

🇺🇸

CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States

and more 13 locations

Docetaxel Plus Carboplatin in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Phase 2
Conditions
Endometrial Cancer
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
First Posted Date
2003-01-27
Last Posted Date
2014-01-06
Lead Sponsor
Herbert Irving Comprehensive Cancer Center
Target Recruit Count
40
Registration Number
NCT00003560
Locations
🇺🇸

Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, United States

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