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

• Adenocarcinoma of unknown primary
• Bladder cancer
• Breast cancer
• Cervical cancer
• Esophageal cancer
• Ewing sarcoma
• Gastric cancer
• Head and neck cancer
• Leiomyosarcoma
• Melanoma
• Nasopharyngeal carcinoma
• Non-small cell lung cancer
• Osteosarcoma
• Ovarian cancer
• Pancreatic cancer
• Penile cancer
• Prostate cancer
• SCC of unknown primary
• Soft tissue sarcoma
• Small cell lung cancer

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

Breast cancer

• 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: Indication revised for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. (no longer limited to prior anthracycline-based chemotherapy exposure)
• 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. (no longer limited to the relapsed or metastatic setting)

Gastric 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. (New disease entity)

Head and neck cancer

• 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). (New disease entity)
• 9/28/2007: Approved for use in combination with cisplatin and fluorouracil (5-FU) for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). (Requirement that disease be inoperable was removed)

Non-small cell lung cancer

• 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. (New disease entity)
• 11/27/2002: Label expanded: 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. (no longer limited to prior chemotherapy exposure)

Prostate cancer

• 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. (New disease entity)

Also known as

• Code names: NSC 628503, RP 56976
• Brand names: Asodocel, Daxotel, Docefrez, Docegem, Doceglob, Docemax, Docenat, Docepar, Docetax, Docetec, Docetere, DoceXan, Docshil, Dolectran, Doxel, Doxetal, Hentaxel, Neocel, Oncodocel, Plustaxano, Sibatere, Taceedo, Taxe-RTU, Taxewell, Taxotere, Texot, Trixotene, Uvtere