Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT00094003
Eligibility Criteria:
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00094003
Study Brief:
Protocol Section:
NCT00094003