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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
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Neoadjuvant Therapy With Docetaxel and Ketoconazole in Patients With High-Risk Prostate Cancer: A Pilot Study

Not Applicable
Conditions
Prostate Cancer
Interventions
First Posted Date
2009-03-27
Last Posted Date
2009-03-27
Lead Sponsor
Kansas City Veteran Affairs Medical Center
Target Recruit Count
20
Registration Number
NCT00870714
Locations
🇺🇸

Kansas City VAMC, Kansas City, Missouri, United States

Open Label Trial of INCB07839 to Determine Effect and Safety of INCB007839 Plus Trastuzumab in HER2 Positive Metastatic Breast Cancer

Phase 1
Terminated
Conditions
Breast Cancer
Interventions
First Posted Date
2009-03-18
Last Posted Date
2018-01-18
Lead Sponsor
Incyte Corporation
Target Recruit Count
68
Registration Number
NCT00864175

Chemotherapy or Observation in Treating Patients With Early Stage Non-Small Cell Lung Cancer

Phase 3
Terminated
Conditions
Lung Cancer
Interventions
First Posted Date
2009-03-18
Last Posted Date
2017-03-27
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
34
Registration Number
NCT00863512
Locations
🇺🇸

Good Samaritan Cancer Center, Puyallup, Washington, United States

🇺🇸

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore, Maryland, United States

🇺🇸

Medical City Dallas Hospital, Dallas, Texas, United States

and more 90 locations

Randomized, Multi-center, Open-label, Study of PR104 Versus PR104/Docetaxel in Non-Small Cell Lung Cancer (NSCLC)

Phase 2
Terminated
Conditions
Non-Small Cell Lung Cancer
Interventions
Drug: docetaxel
Drug: PR104
Drug: Granulocyte colony-stimulating factor
First Posted Date
2009-03-16
Last Posted Date
2013-01-10
Lead Sponsor
Proacta, Incorporated
Target Recruit Count
42
Registration Number
NCT00862134
Locations
🇺🇸

VA Sierra Nevada Health Care System, Reno, Nevada, United States

🇺🇸

Kalamazoo Hematology & Oncology, Kalamazoo, Michigan, United States

🇺🇸

WJB Dorn VA Medical Center, Columbia, South Carolina, United States

and more 24 locations

Docetaxel (Taxotere) and Imatinib Mesylate (Gleevec) in Hormone Refractory Prostate Cancer

Phase 1
Terminated
Conditions
Prostate Cancer
Prostatic Neoplasms
Interventions
First Posted Date
2009-03-13
Last Posted Date
2016-06-30
Lead Sponsor
NYU Langone Health
Target Recruit Count
24
Registration Number
NCT00861471
Locations
🇺🇸

Bellevue Hospital, New York, New York, United States

🇺🇸

NYU Clinical Cancer Center, New York, New York, United States

🇺🇸

NYU Tisch Hospital, New York, New York, United States

Prospective Study With FLOT in Patients With Locally Advanced, Limited Metastatic or Extensive Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction

Phase 2
Completed
Conditions
Gastric Cancer
Adenocarcinoma of the Esophagogastric Junction
Interventions
First Posted Date
2009-02-24
Last Posted Date
2016-04-06
Lead Sponsor
Krankenhaus Nordwest
Target Recruit Count
252
Registration Number
NCT00849615
Locations
🇩🇪

Krankenhaus Nordwest, Frankfurt, Germany

A Phase I Study of MK-2206 in Combination With Standard Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors (MK-2206-003)

Phase 1
Completed
Conditions
Locally Advanced, Metastatic Solid Tumors
Interventions
First Posted Date
2009-02-20
Last Posted Date
2019-11-12
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
77
Registration Number
NCT00848718

Trastuzumab Versus Lapatinib as Neoadjuvant Treatment for Her2+ Patients

First Posted Date
2009-02-11
Last Posted Date
2023-03-31
Lead Sponsor
Spanish Breast Cancer Research Group
Target Recruit Count
102
Registration Number
NCT00841828
Locations
🇪🇸

Hospital General de Granollers, Granollers, Barcelona, Spain

🇪🇸

Onkologikoa, Donostia-San Sebastián, Guipuzcoa, Spain

🇪🇸

Hospital Central de Asturias, Oviedo, Asturias, Spain

and more 23 locations

Study of Erlotinib With Docetaxel in Selected Non Small Cell Lung Cancer Patients in First Line Treatment

Phase 2
Completed
Conditions
Non-Small Cell Lung Cancer
Interventions
First Posted Date
2009-02-10
Last Posted Date
2012-10-30
Lead Sponsor
Meir Medical Center
Target Recruit Count
4
Registration Number
NCT00840125
Locations
🇮🇱

Meir Medical Center, Kfar Saba, Israel

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