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
-

Combination Chemotherapy in Treating Women With Breast Cancer That is Metastatic or Cannot be Treated With Surgery

Phase 2
Completed
Conditions
Breast Cancer
First Posted Date
2003-10-15
Last Posted Date
2018-08-13
Lead Sponsor
Wake Forest University Health Sciences
Target Recruit Count
25
Registration Number
NCT00015886
Locations
🇺🇸

Cancer Centers of the Carolinas, Greenville, South Carolina, United States

🇺🇸

East Carolina University School of Medicine, Greenville, North Carolina, United States

🇺🇸

Palmetto Hematology/Oncology Associates, Spartanburg, South Carolina, United States

and more 3 locations

Doxorubicin and Docetaxel in Treating Women With Stage III Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
Biological: Filgrastim
Drug: Docetaxel
Drug: Doxorubicin
Procedure: Surgery
First Posted Date
2003-10-08
Last Posted Date
2012-09-25
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
45
Registration Number
NCT00005800
Locations
🇺🇸

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer

Phase 1
Completed
Conditions
Male Breast Carcinoma
Stage IIIA Breast Cancer
Adult Solid Neoplasm
Inflammatory Breast Carcinoma
Stage IIIB Breast Cancer
Interventions
Drug: Capecitabine
Drug: Docetaxel
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Drug: Tipifarnib
First Posted Date
2003-10-07
Last Posted Date
2015-05-04
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
53
Registration Number
NCT00070252
Locations
🇺🇸

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

🇺🇸

University of Wisconsin Medical School, Milwaukee, Wisconsin, United States

and more 4 locations

A Phase II Trial of Adjuvant Docetaxel in Patients At High Risk of Relapse Following Prostatectomy

Phase 2
Completed
Conditions
Prostate Cancer
First Posted Date
2003-10-06
Last Posted Date
2011-06-08
Lead Sponsor
Sanofi
Target Recruit Count
83
Registration Number
NCT00069888
Locations
🇺🇸

Sanofi-Aventis US, Bridgewater, New Jersey, United States

MS 209 Plus Docetaxel in Treating Patients With Advanced Solid Tumors

Phase 1
Completed
Conditions
Unspecified Adult Solid Tumor, Protocol Specific
First Posted Date
2003-10-01
Last Posted Date
2012-09-24
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Target Recruit Count
30
Registration Number
NCT00004886
Locations
🇫🇷

Centre Oscar Lambret, Lille, France

🇫🇷

Institut Curie - Section Medicale, Paris, France

🇩🇪

Haemato-Onkologische Praxis und Tagesklinik, Munich (Muenchen), Germany

Tariquidar and Docetaxel to Treat Patients With Lung, Ovarian, Renal and Cervical Cancer

Phase 2
Completed
Conditions
Lung Neoplasms
Ovarian Neoplasms
Cervix Neoplasms
Renal Neoplasms
Interventions
Drug: docetaxel
Drug: tariquidar
Other: 99mTc-sestamibi imaging
First Posted Date
2003-09-16
Last Posted Date
2012-10-12
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
48
Registration Number
NCT00069160
Locations
🇺🇸

National Institutes of Health, Bethesda, Maryland, United States

Docetaxel and Carboplatin With or Without Trastuzumab Before Surgery in Treating Women With Locally Advanced Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
Biological: trastuzumab
Drug: carboplatin
Drug: docetaxel
First Posted Date
2003-09-11
Last Posted Date
2020-09-09
Lead Sponsor
Jonsson Comprehensive Cancer Center
Target Recruit Count
74
Registration Number
NCT00068341
Locations
🇺🇸

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States

🇺🇸

Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California, United States

🇺🇸

Wilshire Oncology Medical Group, Incorporated - Pomona, Pomona, California, United States

and more 1 locations

Trastuzumab and Docetaxel in Treating Patients Who Have Metastatic Prostate Cancer That Is Refractory to Hormone Therapy

Phase 2
Completed
Conditions
Prostate Cancer
First Posted Date
2003-08-29
Last Posted Date
2011-10-20
Lead Sponsor
City of Hope Medical Center
Registration Number
NCT00005857
Locations
🇺🇸

University of California Davis Cancer Center, Sacramento, California, United States

🇺🇸

St. Elizabeth's Medical Center of Boston, Brighton, Massachusetts, United States

🇺🇸

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States

and more 1 locations

Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes

Phase 3
Completed
Conditions
Breast Cancer
First Posted Date
2003-08-25
Last Posted Date
2023-06-15
Lead Sponsor
Eastern Cooperative Oncology Group
Registration Number
NCT00004125
Locations
🇺🇸

State University of New York - Upstate Medical University, Syracuse, New York, United States

🇺🇸

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York, United States

🇺🇸

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States

and more 45 locations

Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer

Phase 1
Completed
Conditions
Fallopian Tube Carcinoma
Primary Peritoneal Carcinoma
Recurrent Ovarian Carcinoma
Stage III Ovarian Cancer
Stage IV Ovarian Cancer
Interventions
Radiation: 3-Dimensional Conformal Radiation Therapy
Drug: Chemosensitization/Potentiation Therapy
Drug: Docetaxel
First Posted Date
2003-08-07
Last Posted Date
2016-02-11
Lead Sponsor
Gynecologic Oncology Group
Target Recruit Count
13
Registration Number
NCT00066456
Locations
🇺🇸

University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

🇺🇸

Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States

🇺🇸

Case Western Reserve University, Cleveland, Ohio, United States

and more 4 locations
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