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
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Individualized Drug Treatment for Treating Patients With Pancreatic Cancer

Phase 2
Terminated
Conditions
Pancreatic Cancer
Interventions
First Posted Date
2006-01-13
Last Posted Date
2018-10-24
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Target Recruit Count
249
Registration Number
NCT00276744
Locations
🇺🇸

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

Celecoxib or Observation After Radiation Therapy and Chemotherapy in Treating Patients With Stage II or Stage III Non-Small Cell Lung Cancer

Phase 2
Conditions
Lung Cancer
First Posted Date
2006-01-11
Last Posted Date
2009-02-09
Lead Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Target Recruit Count
80
Registration Number
NCT00274898
Locations
🇫🇷

Centre Hospitalier Sud-Reiunion, Saint Pierre, France

🇫🇷

Hopital Tenon, Paris, France

🇫🇷

Hopital Avicenne, Bobigny, France

and more 12 locations

Phase II Trial Comparing ABI-007 (Abraxane®, Nab®-Paclitaxel) to Taxotere in First Line Therapy of Patients With Stage IV Breast Cancer

Phase 2
Completed
Conditions
Metastatic Breast Cancer
Interventions
Drug: ABI-007
Drug: Docetaxel
First Posted Date
2006-01-11
Last Posted Date
2019-11-21
Lead Sponsor
Celgene
Target Recruit Count
302
Registration Number
NCT00274456
Locations
🇺🇦

Study Sites in Russia and the Ukraine, Kiev, Ukraine

DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (AIPC Study of Calcitriol Enhancing Taxotere [ASCENT-2])

Phase 3
Terminated
Conditions
Prostate Cancer
First Posted Date
2006-01-09
Last Posted Date
2007-11-06
Lead Sponsor
Novacea
Target Recruit Count
1200
Registration Number
NCT00273338
Locations
🇺🇸

UCLA department of Urology, Los Angeles, California, United States

🇺🇸

Hematology Oncology Associates of Illinois, Chicago, Illinois, United States

🇺🇸

The Cleveland Clinic Foundation, Cleveland, Ohio, United States

and more 209 locations

Avastin/Docetaxel/Carboplatin in Non-Small Cell Lung Cancer

Phase 2
Completed
Conditions
Non-Small Cell Lung Cancer
Interventions
First Posted Date
2006-01-02
Last Posted Date
2020-05-11
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
43
Registration Number
NCT00271505
Locations
🇺🇸

Lyndon Baines Johnson General Hospital, Houston, Texas, United States

🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Neoadjuvant Chemotherapy + Herceptin in HER2 Positive Stage II-III Breast Cancer Patients

Phase 2
Completed
Conditions
Breast Neoplasm
Interventions
First Posted Date
2005-12-29
Last Posted Date
2012-03-20
Lead Sponsor
Accelerated Community Oncology Research Network
Target Recruit Count
30
Registration Number
NCT00270894
Locations
🇺🇸

Arena Oncology Associates, Great Neck, New York, United States

🇺🇸

Advanced Medical Specialties, Miami, Florida, United States

🇺🇸

Northwest Georgia Oncology Centers, PC, Marietta, Georgia, United States

and more 4 locations

The Efficacy and Safety of Gemcitabine in Combination With Docetaxel to Treat Pancreatic or Biliary Cancer

Phase 2
Completed
Conditions
Pancreatic Neoplasms
Biliary Tract Neoplasms
Interventions
First Posted Date
2005-12-23
Last Posted Date
2011-06-30
Lead Sponsor
ARCAGY/ GINECO GROUP
Target Recruit Count
45
Registration Number
NCT00268840
Locations
🇫🇷

Hôpital Hôtel Dieu, Paris, France

Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Gynecological Cancer Patients

Phase 1
Completed
Conditions
Ovarian Cancer
Endometrial Cancer
Peritoneal Cancer
Cervical Cancer
Fallopian Tube Cancer
Breast Cancer
Interventions
Drug: Docetaxel
Drug: PTK787
First Posted Date
2005-12-23
Last Posted Date
2018-07-27
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
24
Registration Number
NCT00268918
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

S0427, Combination Chemotherapy & RT in Treating Patients With Stage III or Stage IV Cancer of the Oropharynx

Phase 3
Terminated
Conditions
Head and Neck Cancer
Interventions
Drug: cisplatin
Radiation: radiation therapy
Drug: docetaxel
Drug: 5-fluorouracil
Procedure: surgery
First Posted Date
2005-12-22
Last Posted Date
2012-10-04
Lead Sponsor
SWOG Cancer Research Network
Target Recruit Count
6
Registration Number
NCT00268372
Locations
🇺🇸

John H. Stroger, Jr. Hospital of Cook County, Chicago, Illinois, United States

🇺🇸

Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois, United States

🇺🇸

University of Mississippi Medical Center, Jackson, Mississippi, United States

and more 69 locations

Pilot Efficacy Study of PI-88 With Docetaxel to Treat Prostate Cancer

Phase 2
Completed
Conditions
Prostate Cancer
Interventions
First Posted Date
2005-12-22
Last Posted Date
2011-06-15
Lead Sponsor
Progen Pharmaceuticals
Target Recruit Count
48
Registration Number
NCT00268593
Locations
🇦🇺

St George Hospital, Kogarah, New South Wales, Australia

🇦🇺

Sydney Haematology and Oncology Clinics, Hornsby, New South Wales, Australia

🇦🇺

Lismore Base Hospital, Lismore, New South Wales, Australia

and more 5 locations
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