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Taxotere

Manufactured by Sanofi
Sourced in France, Canada, United States, Spain, Italy

Taxotere is a pharmaceutical product used in the treatment of certain types of cancer. It is a cytotoxic agent that acts by disrupting the normal function of microtubules, which are important components of cells. The core function of Taxotere is to inhibit cell division and proliferation, thereby suppressing the growth of cancer cells. Taxotere is typically administered intravenously as part of a chemotherapy regimen.

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31 protocols using taxotere

1

Docetaxel Formulation for In Vitro and In Vivo Studies

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To mimic the marketed formulation of DTX, Taxotere® (Sanofi-aventis, Laval, QC, Canada), DTX solution (DTX-Sol) was prepared as a reference. DTX was dissolved in distilled water containing 25% (w/v) of Tween 80 and 9.75% (v/v) of ethanol at a concentration of 10 mg/mL. For in vitro cytotoxicity studies and in vivo intratumoral injections, DTX-Sol was diluted with culture media and saline at determined concentrations, respectively.
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2

PDX HBCx-8 Xenograft Efficacy Study

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The PDX HBCx-8 xenograft was established from a triple-negative negative breast cancer as previously described81 The in vivo efficacy study was conducted by transplanting HBCx-8 tumor fragments into female 8-week-old Swiss nude mice that were randomly assigned to the control or treated groups (six mice per group) when tumors reached a volume of 60 to 200 mm3. Adriamycin, 2 mg/kg (Doxorubicin, Teva Pharmaceuticals) and cyclophosphamide, 100 mg/kg (Endoxan, Baxter), or docetaxel, 20 mg/kg (Taxotere, Sanofi-Aventis) were given as single injection at day 1 by intraperitoneal (i.p.) and intravenous (i.v.) injections. Bromazepam was given orally at 0.6 mg/kg 5 days/week until ethical sacrifice. Tumor growth was evaluated by measurement of two perpendicular diameters of tumors with a caliper twice per week. Individual tumor volumes were calculated as V = axb 2/2, a being the largest diameter, b the smallest. Mice were ethically sacrificed when the tumor volume reached 1500 mm3.
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3

Combinatorial Chemotherapy and Targeted Therapy

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Two chemotherapy agents, the alkylating agent dacarbazine (DTIC) (Medac, France) and the taxane docetaxel (Sanofi-Aventis, France), and three targeted drugs, the MEK1/2 inhibitor selumetinib, the ERK inhibitor compound 35 (also known as AZ6197) [22 (link)], and the mTORC1/2 inhibitor AZD2014, were used in this study. All targeted therapies were provided by Astra Zeneca (Oncology Bioscience, Cambridge, UK).
In vitro experiments were performed with selumetinib and DTIC. Both compounds were dissolved in DMSO to generate 10 mM stock concentrations, which were dispensed into aliquots and stored at -20°C.
For in vivo experiments, selumetinib was suspended in 0.5% v/v Tween 80 and 0.5% methylcellulose and administered orally at a dose of 25 mg/kg, BID, 5 days/week. AZ6197 was dissolved in 10% DMSO, made up to the required volume with 40% hydroxypropyl β cyclodextrin (HPCD) and administered orally at a dose of 50 mg/kg, QD, 5 days/week. AZD2014 was diluted in 1% polysorbate and administered orally at a dose of 15 mg/kg, QD, 5 days/week. dacarbazine (DTIC) was administered at a dose of 40 mg/kg, for five consecutive days, every 28 days. docetaxel (DOC, Taxotere, Sanofi Aventis) was administered weekly at a dose of 15 mg/kg. All cytotoxic drugs were reconstituted in 0.9% NaCl and administered by intraperitoneal (IP) injection.
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4

Docetaxel Monotherapy for Cancer

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Docetaxel (Taxotere®; Sanofi K.K., Japan) monotherapy was administered over the course of 1 h at a dose of 60 mg m−2 once every 3 weeks to patients with an adequate bone marrow reserve. Dexamethasone was administered at a dose of 8 mg before docetaxel treatment.
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5

Combined SPI-1620 and Docetaxel Therapy

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Eligible patients received 11 μg m−2 of SPI-1620 intravenously (IV) over 1 min on day 1 of each cycle, with dose reductions permitted to 9 and 7 μg m−2 for toxicity. At 10 min (±2) after SPI-1620 administration, patients received docetaxel 75 mg m−2 IV, with dose modification in accordance with the Taxotere (Sanofi-aventis Bridgewater, NJ, USA) prescribing information. This regimen was repeated in 3-week (21-day) cycles until progression or intolerable toxicity. Specific dose modification and treatment interruption criteria for docetaxel and SPI-1620 were applied. If docetaxel was held for specific toxicity, then SPI-1620 was held; however, if SPI-1620 was held because of toxicity, then docetaxel was given by itself. Docetaxel dose modification was permitted, as per Taxotere prescribing information. Two dose reductions were allowed for SPI-1620. The SPI-1620 dose reduction or discontinuations were necessary in the event of hypersensitivity reactions, hypotension, or bronchospasm. For mild-to-moderate infusion reactions, the infusion rate was decreased by 50% for the remainder of the dose. If severe infusion reactions occur, discontinuation of therapy was recommended.
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6

Docetaxel and Paclitaxel Formulation Protocol

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Docetaxel (USP 30, grade 99.0%) and paclitaxel (USP 28, grade >99.5%) were supplied by 21CECpharm (London, UK). Poly(methyl vinyl ether-co-maleic anhydride) or poly(anhydride) (PMV/MA) [Gantrez® AN 119; MW 200, 000; density: 1.03 g/mL] was purchased from International Specialty Products ISP/Ahsland Inc. (KY, USA). Taxotere® from Sanofi-Aventis was provided by the Pharmacy Service of University Clinic of Navarra (Pamplona, Spain).
Phosphate buffered saline (PBS), pancreatin and glycine were obtained from Sigma Aldrich (MO, USA). Poly(ethylene glycol) with MW of 2000 and 6000 Da (PEG2000 and PEG6000, respectively) and disodium edetate (EDTA) were provided by Fluka (Buchs, Switzerland).
Pepsin, acetone, ethanol, t-buthylmethylether and acetonitrile were obtained from Merck (Darmstadt, Germany). Polysorbate 80 (Tween® 80) was supplied by Panreac (Barcelona, Spain). Deionised reagent water (18.2 MΩ resistivity) was prepared by a water purification system (Wasserlab, Pamplona, Spain). The anaesthetic isoflurane (Isoflo®) was from laboratories Esteve (Barcelona, Spain). All others reagents and chemicals used were of analytical grade.
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7

Triplet Chemotherapy for Advanced Gastric Cancer

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It was a dose-finding study evaluating safety and activity of triplet chemotherapy association, consisting of DTX, 5-FU and OXP, as first line treatment in advanced GC patients. Triplet chemotherapy association was administered according to the following schedule: DTX (Taxotere; Sanofi-Aventis, Milan, Italy), administered over 60 minutes as intravenous infusion in 250 ml of NaCl 0.9%, at the dose of 50 mg/m2 d1, 15; TFI/5-FU (Fluorouracil Teva®, Teva), 700-800-900-1000 mg/m2/die, over 12-hour (from 10:00 p.m to 10:00 a.m.), d1-2, 8-9, 15-16 and 22-23; OXP (Eloxatin; Sanofi-Aventis, Milan, Italy), over 2-hours as an intravenous infusion in 250 ml of dextrose 5%, at the dose of 60-70-80 mg/m2 d8, 22. Cycles repeated every 4 weeks. 5-FU was administered by a portable pump (CADD Plus, SEVIT) using a venous access device.
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8

Dilution of Chemotherapeutic Agents

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Irinotecan (Mayne Pharma, Raleigh, NC, USA), Paclitaxel (Hospita, Canada), and Docetaxel (Taxotere®; Sanofi Aventis, Bridgewater, NJ, USA) were kindly provided by Dr. Aru Narendran, University of Calgary. These agents were diluted with the respective medium just before use for in vitro studies and with phosphate-buffered saline (PBS) for in vivo studies.
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9

XELOX-TX Regimen for Advanced Solid Tumors

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Eligible patients received oral capecitabine (Xeloda®; Roche, Basel, Switzerland) - 1000 mg/m2 twice daily on days 1 to 10 every 2 weeks, plus oxaliplatin (Eloxatin®, Sanofi-Aventis, Paris, France) 85 mg/m2 (2 h IV infusion) on day 1 (XELOX regimen) every 2 weeks for 6 cycles (Figure 1). Patients were allowed to rest for 1 week after XELOX treatment. Then the treatment was shifted to docetaxel (Taxotere®, Sanofi-Aventis, Paris, France) 30 mg/m2 (a 30-min intravenous infusion) on days 1 and 8, plus oral capecitabine 825 mg/m2 twice daily on days 1 to 14 (TX regimen) every 3 weeks for 4 cycles. After completing all planned regimens, a further regimen was independently decided by the investigator. Prophylactic dexamethasone was prescribed to prevent any potential hypersensitivity reactions to docetaxel. The standard antiemetic prophylaxis of intravenously administered 5-HT3 antagonists was administered before chemotherapy. Granulocyte colony-stimulating factor was administered to treat neutropenic events; however, prophylactic granulocyte colony-stimulating factor and prophylactic antibiotics were not administered to patients who had experienced a neutropenic event in the previous cycle.
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10

Docetaxel for Metastatic Prostate Cancer

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This was a single‐arm, prospective, multicenter, observational study conducted in China. The study included adult patients (≥18 years) with histologically confirmed metastatic prostate adenocarcinoma who had received ≥1 dose of docetaxel (Taxotere®, Sanofi, France) following failure of hormonal therapy (disease progression and serum testosterone <50 ng/dL). Patients with a history of hypersensitivity to docetaxel, with neuroendocrine differentiation, or those who were participating or planning to participate in other clinical trials were excluded. During the study, docetaxel was administered in accordance with the local product label (docetaxel 75 mg/m2 every 3 weeks IV, plus prednisone 5 mg twice a day) and at the discretion of the investigator. The study protocol was approved by the institutional review boards of Fudan University Shanghai Cancer Center (No. 110699‐3). All patients provided written informed consent, and the study was conducted according to the principles of the Declaration of Helsinki. Analysis and reporting was guided by recommendations based on Strengthening the Reporting of Observational Studies in Epidemiology (STROBE).19
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