Docetaxel (Taxotere)

General information

Class/mechanism: Taxane; disrupts normal microtubular function. Binds to free tubulin, promotes their assembly into stable microtubules, and inhibits their disassembly, which inhibits mitosis.
Route: IV
Extravasation: irritant, rare vesicant

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.

Diseases for which it is used

• Bone sarcoma
• Breast cancer
• Cervical cancer
• Esophageal cancer
• Gastric cancer
• Head and neck cancer
• Melanoma
• Non-small cell lung cancer
• Ovarian cancer
• Pancreatic cancer
• Prostate cancer
• Soft tissue sarcoma
• Small cell lung cancer
• Unknown primary

Patient drug information

• Docetaxel (Taxotere) patient drug information (Chemocare)
• Docetaxel (Taxotere) package insert pages 16-17
• Docetaxel (Taxotere) patient drug information (UpToDate)

History of changes in FDA indication

• 5/14/1996: Initial FDA approval for treatment of patients with locally advanced or metastatic breast cancer who have progressed during anthracycline-based therapy or have relapsed during anthracycline-based adjuvant therapy.
• 6/22/1998: Breast cancer indication revised for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.
• 12/23/1999: Label expanded to include treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy.
• 11/27/2002: Lung cancer indication revised:
  • As a single agent, is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy.
  • In combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition.
• 5/19/2004: Label expanded as follows: in combination with prednisone is indicated for the treatment of patients with androgen independent (hormone refractory) metastatic prostate cancer.
• 8/18/2004: Breast cancer indication expanded: in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.
• 3/22/2006: Label expanded as follows: in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease.
• 10/17/2006: Label expanded as follows: in combination with cisplatin and fluorouracil is indicated for the induction treatment of patients with inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN).

Also known as

Synonyms
Asodocel	Docetax	Docetaxel Comp	Docetaxel Delta Farma	Docetaxel Microsules
Docetaxel Sandoz	Docetere	Dolectran	Doxel	Doxetal
Oncodocel	Plustaxano	N-debenzoyl-N-tert-butoxycarbonyl-10-deacetyl Taxol	Neocel	NSC 628503
RP 56976	Taxotere Aventis	Taxotere Chugai	Texot	Trixotene