Induction Chemotherapy Followed by Chemoradiotherapy (TAX324)
The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced (unresectable, low surgical cure, or organ preservation) SCCHN was evaluated in a randomized, multicenter open-label trial (TAX324). In this study, 501 patients, with locally advanced SCCHN, and a WHO performance status of 0 or 1, were randomized to one of two treatment arms. Patients on the docetaxel arm received docetaxel (T) 75 mg/m 2 by intravenous infusion on day 1 followed by cisplatin (P) 100 mg/m 2 administered as a 30-minute to three-hour intravenous infusion, followed by the continuous intravenous infusion of fluorouracil (F) 1000 mg/m 2 /day from day 1 to day 4. The cycles were repeated every 3 weeks for 3 cycles. Patients on the comparator arm received cisplatin (P) 100 mg/m 2 as a 30-minute to three-hour intravenous infusion on day 1 followed by the continuous intravenous infusion of fluorouracil (F) 1000 mg/m 2 /day from day 1 to day 5. The cycles were repeated every 3 weeks for 3 cycles.
All patients in both treatment arms who did not have progressive disease were to receive 7 weeks of chemoradiotherapy (CRT) following induction chemotherapy 3 to 8 weeks after the start of the last cycle. During radiotherapy, carboplatin (AUC 1.5) was given weekly as a one-hour intravenous infusion for a maximum of 7 doses. Radiation was delivered with megavoltage equipment using once daily fractionation (2 Gy per day, 5 days per week for 7 weeks for a total dose of 70-72 Gy). Surgery on the primary site of disease and/or neck could be considered at anytime following completion of CRT.
The primary efficacy endpoint, overall survival (OS), was significantly longer (log-rank test, p=0.0058) with the docetaxel-containing regimen compared to PF (median OS: 70.6 vs 30.1 months respectively, hazard ratio [HR]=0.70, 95% confidence interval [CI]= 0.54-0.90). Overall survival results are presented in Table 21 and Figure 10.
|Endpoint||Docetaxel + Cisplatin+ Fluorouracil n=255||Cisplatin+ Fluorouracil n=246|
|A Hazard ratio of less than 1 favors docetaxel + cisplatin + fluorouracil|
|Median overall survival (months) (95% CI)||70.6 (49.0-NE)||30.1 (20.9-51.5)|
|Hazard ratio: (95% CI) *p-value||0.70 (0.54-0.90) 0.0058|
NE — not estimable
1. “OSHA Hazardous Drugs.” http://www.osha.gov/SLTC/hazardousdrugs/index.html
One-vial Docetaxel Injection
Docetaxel Injection is supplied in multiple-dose (20 mg/mL, 80 mg/4 mL and 160 mg/8 mL) vials as a sterile, pyrogen-free, non-aqueous solution.
Docetaxel Injection Multiple-Dose Vials
Docetaxel Injection 160 mg/8 mL: The vial is in one carton. NDC 16729-267-65
Docetaxel Injection 80 mg/4 mL: The vial is in one carton. NDC 16729-267-64
Docetaxel Injection 20 mg/mL: The vial is in one carton. NDC 16729-267-63
Store between 15°C and 25°C (59°F and 77°F). Retain in the original package to protect from light. Freezing does not adversely affect the product.
After initial puncture, Docetaxel Injection multiple dose vials are stable for 28 days when stored at room temperature, with protection from light.
Docetaxel Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Bone Marrow Suppression
Advise patients that periodic assessment of their blood count will be performed to detect neutropenia, thrombocytopenia, and/ or anemia [see Contraindications (4), Warnings and Precautions (5.3)]. Instruct patients to monitor their temperature frequently and immediately report any occurrence of fever.
Enterocolitis and Neutropenic Colitis
Advise patients of the symptoms of colitis, such as abdominal pain or tenderness, and/or diarrhea, with or without fever, and instruct patients to promptly contact their healthcare provider if they experience these symptoms [see Dosage and Administration (2.7) and Warnings and Precautions (5.4)].
Ask patients whether they have previously received paclitaxel therapy, and if they have experienced a hypersensitivity reaction to paclitaxel. Instruct patients to immediately report to their healthcare provider signs of a hypersensitivity reaction [see Contraindications (4), Warnings and Precautions (5.5)].
Advise patients to report signs of fluid retention such as peripheral edema in the lower extremities, weight gain, and dyspnea immediately to their healthcare provider [see Warnings and Precautions (5.6)].
Second Primary Malignancies
Advise patients on the risk of second primary malignancies during treatment with Docetaxel Injection [see Warnings and Precautions (5.7)].
Advise patients that localized erythema of the extremities and severe skin toxicities may occur. Instruct patients to immediately report severe cutaneous reactions to their healthcare provider [see Dosage and Administration (2.7) and Warnings and Precautions (5.8)].
Advise patients that neurosensory symptoms or peripheral neuropathy may occur. Instruct patients to immediately report neurologic reactions to their healthcare provider [see Dosage and Administration (2.7) and Warnings and Precautions (5.9)].
Advise patients that vision disturbances and excessive tearing are associated with Docetaxel Injection administration. Instruct patients to immediately report any vision changes to their healthcare provider [see Warnings and Precautions (5.10)] .
Explain to patients that nausea, vomiting, diarrhea, and constipation are associated with Docetaxel Injection administration. Instruct patients to report any severe events to their healthcare provider [see Adverse Reactions (6)] .
Advise patients to report any irregular and/or rapid heartbeat, severe shortness of breath, dizziness, and/or fainting immediately to their healthcare provider [see Adverse Reactions (6)] .
Other Common Adverse Reactions
Advise patients that other common adverse reactions associated with Docetaxel Injection may include alopecia (cases of permanent hair loss have been reported), asthenia, anorexia, dysgeusia, mucositis, myalgia, nail disorders, or pain. Instruct patients to report these reactions to their healthcare provider if serious events occur [see Adverse Reactions (6)] .
Importance of Corticosteroids
Explain the significance of oral corticosteroids such as dexamethasone administration to the patient to help facilitate compliance. Instruct patients to report to their healthcare provider if they were not compliant with the oral corticosteroid regimen [see Dosage and Administration (2.6)] ].
Docetaxel can cause fetal harm. Advise patients to inform their healthcare provider of a known or suspected pregnancy. Advise patients to avoid becoming pregnant while receiving this drug. Advise female patients of reproductive potential to use effective contraceptives during treatment and for 6 months after the last dose of docetaxel. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of docetaxel [see Warnings and Precautions (5.12), and Use in Specific Populations (8.1, 8.3)].
Advise women not to breastfeed during docetaxel treatment and for 1 week after the last dose [see Use in Specific Populations (8.2)] .
Advise males of reproductive potential that docetaxel may impair fertility [see Nonclinical Toxicology (13.1)] .
Alcohol Content in Docetaxel Injection
Explain to patients the possible effects of the alcohol content in docetaxel, including possible effects on the central nervous system [see Warnings and Precautions (5.13)] .
Tumor Lysis Syndrome
Advise patients of the potential risk of tumor lysis syndrome and to immediately report any signs or symptoms associated with this event (nausea, vomiting, confusion, shortness of breath, seizure, irregular heartbeat, dark or cloudy urine, reduced amount of urine, unusual tiredness, muscle cramps) to their healthcare provider. Advise patients of the importance of keeping scheduled appointment for blood work or other laboratory tests and of drinking adequate fluids to avoid dehydration. [see Warnings and Precautions (5.14)] .
Ability to Drive or Operate Machines
Explain to patients that docetaxel may impair their ability to drive or operate machines due to its side effects [see Adverse Reactions (6)] or due to the alcohol content of docetaxel [see Warnings and Precautions (5.13)] . Advise them not to drive or use machines if they experience these side effects during treatment.
Inform patients about the risk of drug interactions and the importance of providing a list of prescription and non-prescription drugs to their healthcare provider [see Drug Interactions (7)] .
Manufactured For: Accord Healthcare, Inc.,
1009, Slater Road, Suite 210-B,
Durham, NC 27703,
Manufactured By: Intas Pharmaceuticals Limited,
Ahmedabad – 380 054, India.
10 0739 3 6000259
Issued July 2020
|This Patient Information has been approved by the U.S. Food and Drug Administration.||July 2020|
|Patient Information Docetaxel (doe-se-TAKS-el) Injection for intravenous use|
| What is the most important information I should know about Docetaxel Injection?
Docetaxel Injection can cause serious side effects, including death.
|What is Docetaxel Injection? Docetaxel Injection is a prescription anticancer medicine used to treat certain people with:|
|It is not known if Docetaxel Injection is effective in children.|
Do not receive Docetaxel Injection if you:
|Before you receive Docetaxel Injection, tell your healthcare provider about all of your medical conditions, including if you: |
| How will I receive Docetaxel Injection? |
| What are the possible side effects of Docetaxel Injection? Docetaxel Injection may cause serious side effects including death. |
The most common side effects of Docetaxel Injection include:
| || |
|Tell your healthcare provider if you have a fast or irregular heartbeat, severe shortness of breath, dizziness or fainting during your infusion. If any of these events occurs after your infusion, get medical help right away. Docetaxel Injection may affect fertility in males. Talk to your healthcare provider if this is a concern for you. These are not all the possible side effects of Docetaxel Injection. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088.|
|General information about the safe and effective use of Docetaxel Injection Medicines are sometimes prescribed for purposes other than those listed in this Patient Information. You can ask your pharmacist or healthcare provider for information about Docetaxel Injection that is written for health professionals.|
Active ingredient: docetaxel anhydrous USP
Inactive ingredients: anhydrous citric acid, polysorbate 80 and dehydrated alcohol solution
Manufactured For: Accord Healthcare, Inc., 1009, Slater Road, Suite 210-B, Durham, NC 27703, USA.
Manufactured By: Intas Pharmaceuticals Limited, Ahmedabad – 380 054, India. For more information call 1-866-941-7875
Every three-week injection of Docetaxel Injection for breast, non-small cell lung and stomach, and head and neck cancers
Take your oral corticosteroid medicine as your healthcare provider tells you.
Oral corticosteroid dosing:
Day 1 Date:________ Time:_____ AM______ PM
Day 2 Date:________ Time:_____ AM______ PM
(Docetaxel Injection Treatment Day)
Day 3 Date:________ Time:_____ AM______ PM
Every three-week injection of Docetaxel Injection for prostate cancer Take your oral corticosteroid medicine as your healthcare provider tells you.
Oral corticosteroid dosing:
(Docetaxel Injection Treatment Day)
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.