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Uses

Ovarian Cancer

Conventional paclitaxel: Treatment of advanced carcinoma of the ovary. Used as first-line therapy with carboplatin or cisplatin; this regimen is considered the treatment of choice for primary therapy of advanced ovarian cancer. Used alone or in combination therapy as second-line (salvage) therapy or subsequent therapy in patients with advanced ovarian epithelial cancer.

Breast Cancer

Conventional paclitaxel: Adjuvant therapy in patients with evidence of axillary node tumor involvement; administered sequentially to standard doxorubicin-containing combination therapy.

Conventional paclitaxel: Treatment of breast cancer in patients who have metastatic disease refractory to combination chemotherapy or who have experienced relapse within 6 months of adjuvant chemotherapy; prior therapy should have included an anthracycline antineoplastic agent (e.g., doxorubicin) unless clinically contraindicated.

Conventional paclitaxel: Treatment of breast cancer in combination with trastuzumab for tumors that overexpress the HER2 protein.

Albumin-bound paclitaxel: Used alone for the treatment of breast cancer in patients who have metastatic disease refractory to conventional combination chemotherapy or who have experienced relapse within 6 months of adjuvant therapy; prior therapy should have included an anthracycline antineoplastic agent (e.g., doxorubicin) unless clinically contraindicated.

Non-small Cell Lung Cancer

Conventional paclitaxel: First-line treatment of non-small cell lung carcinoma in combination with carboplatin or cisplatin in patients for whom potentially curative surgery and/or radiation therapy are not possible.

Conventional paclitaxel: Adjuvant therapy† in selected patients with completely resected non-small cell lung cancer; used in conjunction with a platinum agent (e.g., carboplatin).

Small Cell Lung Cancer

Conventional paclitaxel: Active in the treatment of small cell lung carcinoma†.

AIDS-related Kaposi’s Sarcoma

Conventional paclitaxel: Second-line therapy for the palliative treatment of advanced or refractory AIDS-related Kaposi’s sarcoma (designated an orphan drug by FDA for this use).

Esophageal Cancer

Conventional paclitaxel: Has been used for the treatment of esophageal cancer† .

Bladder Cancer

Conventional paclitaxel: Active in the treatment of transitional cell bladder cancer†.

Head and Neck Cancer

Conventional paclitaxel: Active in the treatment of advanced (metastatic or locally recurrent) squamous cell carcinoma of the head and neck†.

Cervical Cancer

Conventional paclitaxel: Active in the treatment of cervical cancer.

Endometrial Cancer

Conventional paclitaxel: Has been used for the treatment of endometrial cancer†.

Dosage and Administration

General

• Consult specialized references for procedures for proper handling and disposal of antineoplastic drugs.
• Conventional paclitaxel: Premedicate all patients before paclitaxel administration to prevent severe hypersensitivity reactions. Oral dexamethasone 20 mg (10 mg for HIV-infected patients) administered approximately 12 and 6 hours before paclitaxel as well as IV diphenhydramine hydrochloride (or similar antihistamine) 50 mg and either IV cimetidine hydrochloride (300 mg of cimetidine) or ranitidine hydrochloride (50 mg of ranitidine) administered 30–60 minutes before paclitaxel can be given.
• Albumin-bound paclitaxel: Premedication not required.

Administration

IV Administration

Handle cautiously (by trained nonpregnant personnel); use protective equipment (e.g., gloves) and wash hands after removal of the gloves.

Immediately treat accidental contact with skin by thoroughly washing with soap and water; immediately treat accidental contact with mucous membranes by thoroughly washing with water. Dyspnea, chest pain, ocular burning, sore throat, and nausea reported upon inhalation.

Conventional Paclitaxel

For solution and drug compatibility information, see Compatibility under Stability.

Administer by IV infusion.

Contact of undiluted paclitaxel for injection concentrate with plasticized polyvinyl chloride (PVC) equipment or devices used to prepare solutions for infusion is not recommended. Diethylhexyl phthalate (DEHP) can be leached from PVC containers.

Diluted paclitaxel solutions preferably should be stored in glass or polypropylene containers or in plastic (polypropylene or polyolefin) bags and administered through polyethylene-lined administration sets.

A hydrophilic, microporous inline filter with a pore size ≤0.22 mcm is necessary during administration. Use of filter devices such as IVEX-2^® filters, which incorporate short inlet and outlet PVC-coated tubing, has not resulted in significant leaching of DEHP.

Do not use a Chemo Dispensing Pen^® or similar device; these devices may cause the stopper to collapse and contaminate the solution (resulting in loss of sterility).

Dilution of Conventional Paclitaxel

The concentrate for injection must be diluted prior to administration.

Dilute in 0.9% sodium chloride injection, 5% dextrose injection, 5% dextrose and 0.9% sodium chloride injection, or 5% dextrose in Ringer’s injection to a final paclitaxel concentration of 0.3–1.2 mg/mL.

Rate of Administration of Conventional Paclitaxel

Infuse appropriate dose IV over 3 or 24 hours, depending on the treatment regimen.

Albumin-bound Paclitaxel

Administer by IV infusion; do not use inline filters.

Reconstitution of Albumin-bound Paclitaxel

Add 20 mL of 0.9% sodium chloride injection to a vial containing 100 mg of paclitaxel lyophilized powder; slowly inject the diluent onto the inside wall of the vial. Allow the vial to sit for ≥5 minutes (to ensure wetting of cake/powder); then, gently swirl and/or invert vial for ≥2 minutes. Handle in such a manner to avoid foaming. Resulting preparation contains 5 mg/mL.

Withdraw appropriate dose from vial and transfer to an empty sterile PVC IV bag. DEHP-free containers and administration sets not needed.

Rate of Administration of Albumin-bound Paclitaxel

Infuse appropriate dose IV over 30 minutes. Limiting infusion duration to 30 minutes reduces risk of infusion-related reactions.

Dosage

Adults

Ovarian Cancer

IV (Conventional Paclitaxel)

Previously untreated patients: 175 mg/m² given over 3 hours followed by cisplatin 75 mg/m² in repeated 3-week cycles. Alternatively, 135 mg/m² given over 24 hours followed by cisplatin 75 mg/m² in repeated 3-week cycles.

Previously treated patients: 135 mg/m² or 175 mg/m² given over 3 hours in repeated 3-week cycles.

Reduce dose by 20% for subsequent cycles in patients who experience severe neutropenia (neutrophil count <500/mm³ for >7 days) or severe peripheral neuropathy.

Breast Cancer

IV (Conventional Paclitaxel)

Adjuvant therapy: 175 mg/m² given over 3 hours in repeated 3-week cycles for 4 cycles administered sequentially to doxorubicin-containing chemotherapy.

Treatment after failure of initial therapy for metastatic disease or relapse within 6 months of adjuvant therapy: 175 mg/m² given over 3 hours in repeated 3-week cycles.

Reduce dose by 20% for subsequent cycles in patients who experience severe neutropenia (neutrophil count <500/mm³ for >7 days) or severe peripheral neuropathy.

IV (Albumin-bound Paclitaxel)

Treatment after failure of initial therapy for metastatic disease or relapse within 6 months of adjuvant therapy: 260 mg/m² every 3 weeks.

Reduce dose to 220 mg/m² for subsequent cycles in patients who experience severe neutropenia (neutrophil count <500/mm³ for >7 days) or severe sensory neuropathy. Reduce dose to 180 mg/m² if severe neutropenia or severe sensory neuropathy recur. For grade 3 sensory neuropathy, withhold therapy until resolution to grade 1 or 2; when therapy is resumed, reduce dose.

Non-small Cell Lung Cancer

IV (Conventional Paclitaxel)

135 mg/m² given over 24 hours followed by cisplatin 75 mg/m² in repeated 3-week cycles. Alternatively, 175 mg/m² given over 3 hours followed by cisplatin 80 mg/m² in repeated 3-week cycles has been used.

Reduce dose by 20% for subsequent cycles in patients who experience severe neutropenia (neutrophil count <500/mm³ for >7 days) or severe peripheral neuropathy.

AIDS-related Kaposi’s Sarcoma

IV (Conventional Paclitaxel)

135 mg/m² given over 3 hours in repeated 3-week cycles. Alternatively, 100 mg/m² over 3 hours in repeated 2-weeks cycles. The regimen given every 3 weeks is more toxic than the regimen given every 2 weeks; patients with poor performance status have been treated with paclitaxel 100 mg/m².

Reduce dose by 20% for subsequent cycles in patients who experience severe neutropenia (neutrophil count <500/mm³ for >7 days); initiate granulocyte colony stimulating factor (G-CSF) as indicated.

Special Populations

Dosage in Hepatic Impairment

Conventional paclitaxel: Increased risk of toxicity, particularly grade III-IV myelosuppression. Adjust dosage as follows.

Data not available to make dosage recommendation in patients with AIDS-related Kaposi’s sarcoma.

Albumin-bound paclitaxel: Appropriate dosage for patients with serum bilirubin >1.5 mg/dL not established.

Dosage in Renal Impairment

Conventional paclitaxel: Reduction of dosage does not appear to be necessary.