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 established (work in progress)

• Breast cancer
• Gastric cancer
• Head and neck cancer
• Non-small cell lung cancer
  • Non-small cell lung cancer, nonsquamous
  • Non-small cell lung cancer, squamous
• Ovarian cancer
• Prostate cancer

Diseases for which it is used

• Carcinoma of unknown primary
• Anal cancer
• Cervical cancer
• Esophageal cancer
  • Esophageal adenocarcinoma
  • Esophageal squamous cell carcinoma
• Ewing sarcoma
• Leiomyosarcoma
• Melanoma
• Nasopharyngeal carcinoma
• Osteosarcoma
• Pancreatic cancer
• Penile cancer
• Soft tissue sarcoma
• Small cell lung cancer
• Urothelial carcinoma

Patient drug information

• Docetaxel (Taxotere) package insert
• Docetaxel (Taxotere) patient drug information (Chemocare)
• Docetaxel (Taxotere) patient drug information (UpToDate)

History of changes in FDA indication

Breast cancer

• 1996-05-14: Initial accelerated approval for treatment of patients with metastatic breast cancer who have progressed during anthracycline-based therapy. (Based on TAX 303 & TAX 304)
• 1996-05-14: Initial accelerated approval for treatment of patients with locally advanced breast cancer who have relapsed during anthracycline-based adjuvant therapy. (Based on TAX 303 & TAX 304)
• 1998-06-22: Converted to regular approval and 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; based on TAX 313)
• 2004-08-18: 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; based on BCIRG 001)

Gastric cancer

• 2006-03-22: 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; based on TAX 325)

Head and neck cancer

• 2006-10-17: 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; based on TAX 323)
• 2007-09-28: 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; based on TAX 324)

Non-small cell lung cancer

• 1999-12-23: 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; based on TAX 317 & TAX 320)
• 2002-11-27: 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; based on TAX 326)

Prostate cancer

• 2004-05-19: 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; based on TAX 327)

History of changes in EMA indication

• 1995-11-27: Initial marketing authorization as Taxotere

Breast cancer

• Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.
• 2010-07-01: Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-negative breast cancer. Adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer. (Based on GEICAM 9805)
• Taxotere in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.
• Taxotere monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.
• Taxotere in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.
• Taxotere in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.

Gastric adenocarcinoma

• 2006-04-27: Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.

Head and neck cancer

• 2006-10-23: Extension of indication for induction treatment in combination with cisplatin and 5-fluorouracil of patients with inoperable locally advanced squamous cell carcinoma of the head and neck.
• 2007-11-23: Taxotere in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

Non-small cell lung cancer

• Taxotere is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.
• Taxotere in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.

Prostate cancer

• Uncertain date: Taxotere in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.

History of changes in Health Canada indication

• 1995-07-21: Initial notice of compliance

History of changes in PMDA indication

• 2005-08-18: New indication for the treatment of cancer of the uterus body.
• 2008-08-29: New indication and a new dosage for the treatment of prostate cancer.

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, Taxespira, Taxewell, Taxotere, Texot, Trixotene, Uvtere