Status:
COMPLETED
Study of NS-9 in Patients With Liver Metastases
Lead Sponsor:
NS Pharma, Inc.
Conditions:
Liver Neoplasms
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is to investigate the safety of NS-9 and to see how well it is tolerated in patients with cancer that has metastasized (spread) to the liver from another primary tumor. NS-9 is a drug devel...
Detailed Description
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 pe...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00094003
Start Date
September 1 2002
Last Update
November 11 2005
Active Locations (2)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030