Study on Sorafenib and Doxorubicin for Advanced Liver Cancer After Sorafenib Treatment
Sponsor: Memorial Sloan Kettering Cancer Center
Sponsor score: 60
ClinicalTrials ID:NCT01840592
This clinical trial is exploring the effects of combining two drugs, sorafenib and doxorubicin, to see if they can help control the growth and spread of advanced liver cancer in patients who have already been treated with sorafenib.
Patient Parameters
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Program Overview
The aim of this study is to determine how the combination of two drugs, sorafenib and doxorubicin, affects the growth and spread of advanced liver cancer (HCC) in patients who have previously been treated with sorafenib alone. Researchers want to find out if this combination can provide better control over the cancer.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of liver cancer (HCC), excluding certain types like mixed HCC or fibrolamellar variant.
- Previously treated with sorafenib, with evidence that the cancer has progressed.
- Cancer that can be measured using standard criteria.
- No severe liver disease or only mild cirrhosis (Child-Pugh A).
- Expected to live at least 3 more months.
- Aged 18 years or older.
- Good overall health with a performance score of 70% or higher.
- Fully recovered from any previous surgery or radiation, with none in the last 2 weeks.
- May have had certain liver treatments before, as long as the cancer has grown since then or there are untreated areas.
- Must agree to participate and sign a consent form.
- Specific blood test results within normal ranges, including bilirubin, neutrophil count, platelets, and creatinine.
- Can continue treatment for hepatitis B or C, except interferon.
- Well-controlled blood pressure.
- Brain metastases allowed if stable and without seizures.
- Previous radiation to bones allowed if completed over 2 weeks ago.
Exclusion Criteria
- Serious heart conditions, including recent heart attack or severe heart failure.
- Irregular heartbeats needing specific treatments, except beta blockers or digoxin.
- Heart function below normal levels.
- Participation in other experimental studies.
- Previous treatment with certain liver therapies or doxorubicin.
- Pregnant or breastfeeding women.
- Uncontrolled illnesses or psychiatric conditions affecting study participation.
- History of another cancer, except certain skin or cervical cancers, or other solid tumors without active disease.
- Recent bleeding in the esophagus or stomach.
- Use of certain medications like Rifampin or St John's Wort, which must be stopped 4 weeks before starting the study.
- Known HIV positive status.
- History of bleeding disorders.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Center at Basking Ridge | Basking Ridge | New Jersey | |
| Memorial Sloan Kettering Cancer Center @ Suffolk | 11725 | Commack | New York |
| Memorial Sloan Kettering West Harrison | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Memorial Sloan Kettering Cancer Center at Mercy Medical Center | 11570 | Rockville Centre | New York |
| Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center | 10591 | Sleepy Hollow | New York |
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