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

A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer

Phase 2
Recruiting
Conditions
Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
Interventions
First Posted Date
2024-08-09
Last Posted Date
2025-05-06
Lead Sponsor
Ferring Pharmaceuticals
Target Recruit Count
150
Registration Number
NCT06545955
Locations
🇺🇸

Ferring Investigational Site, Myrtle Beach, South Carolina, United States

An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Docetaxel and Ramucirumab as Second-line Therapy in Patients With Advanced or Recurrent Non-small Cell Lung Cancer

Phase 1
Active, not recruiting
Conditions
Non-small Cell Lung Cancer
Interventions
First Posted Date
2024-08-07
Last Posted Date
2024-08-07
Lead Sponsor
Ono Pharmaceutical Co. Ltd
Target Recruit Count
42
Registration Number
NCT06542731
Locations
🇯🇵

National Cancer Center Hospital, Chuo Ku, Tokyo, Japan

🇯🇵

The Cancer Institute Hospital of JFCR, Koto-ku, Japan

🇯🇵

Teikyo University Hospital, Itabashi-ku, Japan

and more 10 locations

A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer

Phase 1
Active, not recruiting
Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
First Posted Date
2024-08-01
Last Posted Date
2025-05-14
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
12
Registration Number
NCT06532032
Locations
🇹🇷

Ankara Bilkent Sehir Hastanesi, Cankaya, Turkey

🇺🇸

Oncology Hematology Associates, Springfield, Missouri, United States

🇺🇸

Hunterdon Hematology Oncology, Flemington, New Jersey, United States

and more 12 locations

A Study to Evaluate the Efficacy and Safety of the Combination of Glumetinib and Docetaxel(Albumin Bound)Verse Docetaxel for the Treatment of MET-overexpressed Non-small Cell Lung Cancer

Phase 2
Not yet recruiting
Conditions
Locally Advanced/Recurrent or Distant Metastasized Non-small Cell Lung Cancer With MET Overexpression
Interventions
Drug: HB1801 (docetaxel, albumin-bound)
First Posted Date
2024-07-29
Last Posted Date
2024-07-29
Lead Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Target Recruit Count
256
Registration Number
NCT06525350

The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global)

Phase 3
Recruiting
Conditions
Metastatic Castration-resistant Prostate Cancer
Interventions
First Posted Date
2024-07-25
Last Posted Date
2025-02-28
Lead Sponsor
Telix Pharmaceuticals (Innovations) Pty Limited
Target Recruit Count
430
Registration Number
NCT06520345
Locations
🇺🇸

Chao Family Comprehensive Cancer Centre, Orange, California, United States

🇺🇸

Biogenix Molecular LLC, Miami, Florida, United States

🇺🇸

United Theranostics, Glen Burnie, Maryland, United States

and more 9 locations

Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tissue Sarcoma

Phase 1
Suspended
Conditions
Advanced Dedifferentiated Liposarcoma
Advanced Leiomyosarcoma
Advanced Soft Tissue Sarcoma
Metastatic Dedifferentiated Liposarcoma
Metastatic Leiomyosarcoma
Metastatic Soft Tissue Sarcoma
Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
Interventions
Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Other: Fluorothymidine F-18
Procedure: Positron Emission Tomography
First Posted Date
2024-07-12
Last Posted Date
2025-04-17
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
74
Registration Number
NCT06498648
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

A Study of Docetaxel for Injection (Albumin Bound) in Patients With Advanced Pancreatic Cancer

Phase 3
Not yet recruiting
Conditions
Advanced Pancreatic Cancer
Interventions
Drug: Placebo
Drug: Best supportive care
First Posted Date
2024-07-09
Last Posted Date
2024-07-09
Lead Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Target Recruit Count
142
Registration Number
NCT06492941

Intravesical Gemcitabine and Docetaxel for Low Grade Intermediate Risk Bladder Cancer

Phase 2
Recruiting
Conditions
Bladder Cancer
Interventions
First Posted Date
2024-07-05
Last Posted Date
2025-03-05
Lead Sponsor
University of Florida
Target Recruit Count
34
Registration Number
NCT06488222
Locations
🇺🇸

University of Florida, Gainesville, Florida, United States

Ebastine in Combination With Docetaxel as a Treatment for Castration-resistant Metastatic Prostate Cancer

Phase 1
Recruiting
Conditions
Metastatic Castration-resistant Prostate Cancer
Interventions
First Posted Date
2024-06-28
Last Posted Date
2025-04-13
Lead Sponsor
Rigshospitalet, Denmark
Target Recruit Count
30
Registration Number
NCT06480110
Locations
🇩🇰

Department of Oncology 5073, Rigshospitalet, Copenhagen, Denmark

Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Agent (Alone or Combined) or Radiotherapy on Primary Tumor in Addition to Androgen Deprivation Therapy in HOrmone-Sensitive Metastatic Prostate Cancer Patients

Recruiting
Conditions
Prostate Cancer
Hormone Sensitive Prostate Cancer
Metastatic Tumor
Interventions
First Posted Date
2024-06-25
Last Posted Date
2024-06-25
Lead Sponsor
Santa Chiara Hospital
Target Recruit Count
3000
Registration Number
NCT06473259
Locations
🇮🇹

Azienda Ospedaliera San Luigi, Orbassano, Torino, Italy

🇮🇹

Istituto Oncologico Veneto, Padova, Italy

🇮🇹

Santa Chiara Hospital, Trento, Italy

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