CALGB 80802 - PHASE III RANDOMIZED STUDY OF SORAFENIB PLUS DOXORUBICIN VERSUS SORAFENIB IN PATIENTS WIT Hadvanced hepatocellular carcinoma (HCC)
Description
Primary objective:
Compare overall survival (OS) of patients treated with sorafenib and doxorubicin to that of those treated with sorafenib.
Secondary objectives:
Compare time to progression (TTP) of patients treated with sorafenib and doxorubicin to that of those treated with sorafenib.
Compare progression-free-survival (PFS) of patients treated with sorafenib and doxorubicin to that of those treated with sorafenib.
Compare tumor response using RECIST criteria of patients treated with sorafenib and doxorubicin to that of those treated with sorafenib.
Study/Treatment
Hepatocellular Cancer
Inclusion/Notes
Inclusion Criteria:
Pathologically or cytologically proven hepatocellular carcinoma. No known mixed histology or fibrolamellar variant.
Locally advanced or metastatic disease.
Patients must have measurable disease.
No prior adjuvant therapy with sorafenib or other Raf/VEGFR inhibitors. Other prior adjuvant tx is allowed if completed >6 months prior to study entry with documented recurrence of HCC.
Prior locoregional therapies allowed provided that patient either has a target lesion that has not been subjected to local therapy and/or the target lesion(s) within field of local therapy has shown =25% increase in size since last treatment. Such therapy must be completed =4 weeks prior to study entry.
No prior systemic tx for metastatic disease.
Antiviral tx is allowed, but interferon therapy must be stopped =4 weeks prior to registration (Sec 4.4).
Allografts are not allowed, including but not limited to liver and bone marrow transplants.
No known CNS tumors including brain metastases.
No significant GI bleeding events requiring intervention, transfusion, or admission to hospital within 30 days prior to study entry.
=4 weeks since major surgery.
No rifampin or St. John’s Wort.
Hypertension must be well controlled (<140/90 mm Hg).
No known history of congestive heart failure > NYHA II or cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
No myocardial infarction within 6 months prior to study entry.
No known history of serious myocardial dysfunction, defined as scintigraphically determined absolute LVEF below 45% or below the normal limit .
No known history of bleeding diathesis.
Patients receiving combination anti-retroviral therapy for HIV are excluded.
Age =18 years.
ECOG Performance Status: 0-2.
Non-pregnant and non-nursing.
Granulocytes=1,500/µL,Platelets=75,000/µL,
Hemoglobin=8.5 g/dL
PT-INR=1.7, Creatinine =1.5 x ULN or CrCL =60 cc/min)
Bilirubin=3 mg/dL, ALT/AST=5 x ULN
Exclusion criteria:
Substance abuse, medical, psychological or social condition, and psychiatric illness which would prevent the patient from giving informed consent.
Medical conditions such as uncontrolled infection, uncontrolled diabetes mellitus or hypertension which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
Patients with a previous malignancy except for cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors or other malignancies that may influence patient outcome.
Inability to take oral medications.
Life expectancy of = 12 weeks.
Contact Name
Nancy N. and J.C. Lewis Cancer & Research Pavilion
Phone
(912) 819-5704
Nancy N. and J.C. Lewis Cancer & Research Pavilion225 Candler Drive, Savannah, Georgia 31405
