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

Docetaxel With or Without Oblimersen in Treating Patients With Non-Small Cell Lung Cancer

Phase 2
Conditions
Lung Cancer
First Posted Date
2003-01-27
Last Posted Date
2014-01-06
Lead Sponsor
Genta Incorporated
Registration Number
NCT00030641
Locations
🇺🇸

Augusta Oncology Associates, Augusta, Georgia, United States

🇺🇸

Harold Simmons Cancer Center, Dallas, Texas, United States

🇺🇸

West Virginia University Hospitals, Morgantown, West Virginia, United States

and more 41 locations

Sulindac and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
First Posted Date
2003-01-27
Last Posted Date
2014-05-06
Lead Sponsor
Fox Chase Cancer Center
Target Recruit Count
10
Registration Number
NCT00039520
Locations
🇺🇸

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

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

First Posted Date
2003-01-27
Last Posted Date
2016-11-15
Lead Sponsor
Sanofi
Target Recruit Count
3222
Registration Number
NCT00021255
Locations
🇻🇪

Sanofi-Aventis Administrative Office, Caracas, Venezuela

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

Phase 2
Completed
Conditions
Stage IV Breast Cancer
Recurrent Breast Cancer
Interventions
Other: laboratory biomarker analysis
Biological: trastuzumab
First Posted Date
2003-01-27
Last Posted Date
2014-05-23
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
84
Registration Number
NCT00004888
Locations
🇺🇸

Eastern Cooperative Oncology Group, Boston, Massachusetts, United States

Hormone Therapy Compared With Combination Chemotherapy in Treating Patients With Prostate Cancer

Phase 3
Completed
Conditions
Prostate Cancer
First Posted Date
2003-01-27
Last Posted Date
2023-06-15
Lead Sponsor
Eastern Cooperative Oncology Group
Registration Number
NCT00027859
Locations
🇺🇸

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center, Los Angeles, California, United States

🇺🇸

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

🇺🇸

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

and more 95 locations

Chemotherapy With or Without Strontium-89 in Treating Patients With Prostate Cancer

First Posted Date
2003-01-27
Last Posted Date
2016-03-22
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
265
Registration Number
NCT00024167
Locations
🇺🇸

Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, United States

🇺🇸

St. Luke's Regional Medical Center, Sioux City, Iowa, United States

🇺🇸

University of Mississippi Cancer Clinic, Jackson, Mississippi, United States

and more 36 locations

Docetaxel, Estramustine, and Exisulind in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2003-01-27
Last Posted Date
2016-07-01
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
80
Registration Number
NCT00052845
Locations
🇺🇸

Walter Reed Army Medical Center, Washington, District of Columbia, United States

🇨🇦

McGill University, Montreal, Quebec, Canada

🇺🇸

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center, Los Angeles, California, United States

and more 77 locations

Gemcitabine Plus Docetaxel in Treating Patients With Unresectable or Metastatic Liver Cancer

Phase 2
Completed
Conditions
Liver Cancer
Interventions
First Posted Date
2003-01-27
Last Posted Date
2016-12-07
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
25
Registration Number
NCT00006010
Locations
🇺🇸

CCOP - Atlanta Regional, Atlanta, Georgia, United States

🇺🇸

CCOP - Carle Cancer Center, Urbana, Illinois, United States

🇺🇸

Siouxland Hematology-Oncology, Sioux City, Iowa, United States

and more 14 locations

Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery

Phase 3
Withdrawn
Conditions
Adult Solid Tumor
Breast Cancer
Head and Neck Cancer
Kidney and Urinary Cancer
Male Reproductive Cancer
Thorax and Respiratory Cancer
Interventions
Drug: Hypericum perforatum
Other: placebo
First Posted Date
2003-01-27
Last Posted Date
2016-07-12
Lead Sponsor
Alliance for Clinical Trials in Oncology
Registration Number
NCT00041171

Combination Chemotherapy in Treating Patients With Advanced Prostate Cancer

Phase 1
Conditions
Prostate Cancer
First Posted Date
2003-01-27
Last Posted Date
2013-12-19
Lead Sponsor
Herbert Irving Comprehensive Cancer Center
Target Recruit Count
12
Registration Number
NCT00003633
Locations
🇺🇸

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

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