Status:
COMPLETED
TKM 080301 for Primary or Secondary Liver Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer With Hepatic Metastases
Pancreas Cancer With Hepatic Metastase
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief Summary
Background: Cancer in the liver can start in the liver (e.g., primary liver cancer or hepatocellular cancer) or spread to the liver from cancers in other parts of the body (e.g. colon, pancreas, gast...
Detailed Description
BACKGROUND: \- Metastatic liver disease is a life-limiting factor for patients with a variety of cancers. For unresectable liver metastases, the 5-year survival is \< 5%. * For selected histologies...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Histologically or cytologically confirmed colorectal, pancreas, gastric, breast, ovarian and esophageal cancers with hepatic metastases, or primary liver cancers (Hepatocellular carcinoma and Cholangiocarcinoma).
- Hepatic disease must be measurable per RECIST Criteria (version 1.1).
- Hepatic disease should be deemed unresectable as per standard of care criteria.
- Note: Evidence of limited unresectable extrahepatic disease on preoperative radiological studies is acceptable if the life-limiting component of progressive disease is in the liver.
- All patients must have failed to respond to standard regimens or therapies known to provide clinical benefit. For example:
- \- Patients with metastatic colorectal cancer must have received 5-FU and
- leucovorin in combination with either oxaliplatin and/or irinotecan, since level
- 1 evidence support increase survival with these regimens, compared to 5-FU and leucovorin alone.
- \- Patients with hepatocellular carcinoma must have received sorafenib, since level 1 evidence support increase survival.
- Greater than or equal to 18 years of age
- Must be able to understand and sign the Informed Consent Document
- Clinical performance status of ECOG less than or equal to 2
- Life expectancy of greater/equal than two months
- Patients of both genders must be willing to practice birth control during and for four months after receiving chemotherapy
- Hematology:
- Absolute neutrophil count greater than or equal to 1500/mm(3) without the support of filgrastim.
- Platelet count greater than or equal to 100,000/mm(3).
- Hemoglobin greater than or equal to 9.0 g/dl.
- Chemistry:
- Serum ALT/AST less than or equal to 2.5 times the upper limit of normal.
- Serum Albumin greater than or equal to 3.0 g/dL
- Serum creatinine less than or equal to 1.5 times ULN unless the measured
- creatinine clearance is greater than 60 mL/min/1.73 m(2)
- \- Total bilirubin less than or equal to 1.2 mg/dl
- International Normalized Ratio (INR) less than or equal to 1.5
- Seronegative for HIV antibody
- No chemotherapy or any other investigational drugs within 4 weeks of treatment
- LVEF greater than or equal to 50 percent
- QT/QTc interval less than 450 ms
- EXCLUSION CRITERIA:
- Any known brain metastases (prior or current regardless of treatment status)
- Women of child-bearing potential who are pregnant or breastfeeding, because of the potentially dangerous effects of the chemotherapy on the fetus or infant.
- Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune systems, recent myocardial infarction or heart failure (within 6 months of enrollment).
- NYHA greater than or equal to 2
- Childs B or C cirrhosis or with evidence of severe portal hypertension by history, endoscopy, or radiologic studies
- Weight less than 40 kg
- Significant ascites, greater than 1000cc in the absence of peritoneal disease
- Concomitant medical problems that would place the patient at an unacceptable risk for the procedure/drug
- Patient has known hypersensitivity or previous severe reactions to oligonucleotideor lipid-based products, including liposomal drug products (e.g. Doxil) and phospholipid-based products (parenteral nutrition, Intralipid)
- Discretion of the PI
Exclusion
Key Trial Info
Start Date :
August 26 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2012
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01437007
Start Date
August 26 2011
End Date
June 21 2012
Last Update
August 3 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892