Study of NS-9 in Patients With Liver Metastases

This study requires subjects to undergo 2 treatment cycles of NS-9. Each cycle consists of once daily, 1-hour I.V. infusions of the drug for 5 days followed by a 23-day rest period. During the rest period, subjects are seen at the clinic once weekly for evaluation. Subjects having favorable or stable results after 2 cycles may continue to receive NS-9 in the extension phase of the study until the disease progresses or until they get a side effect that prevents them from continuing with therapy.

After each two cycles, if appropriate, the liver tumor will be measured by radiologic imaging to compare it to its pre-treatment size.

Inclusion criteria

• Male and female at least 18 years of age.
• Patients with liver metastases from various primary cancers for which no other curative treatment options exist.
• At least one measurable lesion (by CT or MRI)
• Life expectancy > 3 months
• Child-bearing potential women must have a negative serum pregnancy test
• ECOG performance status: 0-1
• Fully recovered from any previous cancer therapy or infection (at least 4 weeks from radiation or chemotherapy, at least 3 weeks from a major surgical procedure and at least 2 weeks from an exploration/biopsy)
• Discontinued from any other investigational drug for at least 30 days
• Serum calcium <11 mg/dL
• Absolute neutrophil count (ANC) ≥1,500/mm3, without growth factor support
• Hemoglobin ≥9.0 g/dL
• Platelet count ≥100,000/mm3
• Serum creatinine ≤1.5 times the upper limit of normal (ULN)
• Bilirubin ≤1.5 times ULN
• ALT and AST ≤3 times ULN
• Amylase and lipase ≤ ULN
• PT and PTT < 1.5 times ULN
• ECG with no acute abnormalities
• Afebrile (≤37.5C or 99.5F)
• Willingness and ability to comply with all study requirements

Exclusion criteria

• Subject is mentally or legally incapacitated, or has significant emotional or psychiatric problems.
• Concomitant primary malignant and/or non-malignant liver disease (primary liver cancer, acute or chronic hepatitis, cirrhosis, alcoholic liver disease).
• History of pancreatic disease (e.g., pancreatitis, pancreatic malignancy).
• New York Heart Association classification Class III or IV
• Uncontrolled intercurrent illnesses including but not limited to: hypertension, seizure disorder, renal, gastrointestinal, or hematological diseases.
• Clinically relevant systemic disease (other than the malignancy and malignancy-related hepatic dysfunction) making implementation of the protocol or interpretation of the study results difficult.
• Pregnant or nursing, or unwilling to or will not agree to use an effective and reliable contraceptive measure.
• Subject has received radiation to >25% of the total bone marrow.
• Subject has a history of any other illness that would preclude study participation.
• Subject has brain metastases.
• Subject has allergy to egg yolk.
• Subject receiving low-molecular weight heparin for treatment of a blood coagulation disorder (e.g., deep vein thrombosis, pulmonary embolism).