Usual Adult Dose for Pancreatic Cancer

This drug can be given on a daily or weekly basis.

DAILY SCHEDULE:

• Recommended Dose: 500 mg/m2 BSA IV by rapid injection or short/prolonged infusion once a day for 5 consecutive days every 6 weeks.
• Dose escalation is not recommended.
• Duration of Therapy: Until maximum benefit or until treatment-limiting toxicity occurs.

• Initial Dose: 1000 mg/m2 BSA IV by rapid injection or short/prolonged infusion at weekly intervals for first 2 courses.
• Maintenance Dose: After the first 2 courses, doses may be escalated in patients who have not achieved a therapeutic response and who have not experienced significant toxicity with the previous treatment course.
• Maximum Dose: Single dose of 1500 mg/m2 BSA

• The ideal duration of maintenance therapy for both dosing schedules has not been established.
• Therapy should be limited to patients with symptomatic or progressive metastatic disease due to the inherent renal toxicity of this drug.

Renal Dose Adjustments

Data not available.

Liver Dose Adjustments

Data not available.

Precautions

US BOXED WARNINGS: Experienced Physician, Drug Toxicities, and Secondary Malignancies.
EXPERIENCED PHYSICIAN:

• A patient does not need to be hospitalized, but should have access to a facility with laboratory and supportive resources sufficient to monitor drug tolerance and to protect and maintain a patient compromised by drug toxicity.
• This drug should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents.
• The physician should be familiar with this drug and judge the possible benefit against the known toxic effects before beginning treatment with this drug.

• Renal toxicity is dose-related and cumulative, and may be severe or fatal.
• Other major toxicities are nausea and vomiting which may be severe and treatment-limiting at times.
• Liver dysfunction, diarrhea, and hematological changes also have been observed in some patients.

Dialysis

Data not available.

Other Comments

Administration Advice:

• This drug should not be administered intra-arterially as adverse renal effects may be evoked more rapidly by this administration route.
• Gloves should be used when handling this drug.
• Skin or mucosae that come into contact with this drug (powder or prepared solution) should be washed immediately with soap and water.
• Preparation, handling, and disposal of this drug should be performed in a manner consistent with safe procedures for cytotoxic agents.

• Unopened vials should be refrigerated (2 to 8 Celsius) and protected from light (preferably stored in carton).
• The total storage time for this drug after it has been placed in solution should not exceed 12 hours.

• The manufacturer product information should be consulted.

• Responses to this drug have been obtained with both functional and nonfunctional carcinomas.
• For patients with functional tumors, serial monitoring of fasting insulin levels allows a determination of biochemical therapy response.
• For either functional or nonfunctional tumors, therapy response can be determined by measurable reductions of tumor size (reduction of organomegaly, masses, or lymph nodes).
• This drug is not active orally.
• The drug vials contain no preservatives and are not intended for multiple-dose use.
• There is no known specific antidote for this drug.

• Hematologic: CBC (at least weekly during treatment)
• Hepatic: Liver function tests (at least weekly during treatment)
• Renal: Serial urinalysis, BUN, plasma creatinine, serum electrolytes, and CrCl (prior to, at least weekly during, and for 4 weeks after each therapy course)

• This drug may cause side effects such as confusion that can affect your ability to perform certain activities; avoid driving and activities such as operating machinery until you know how this drug affects you.