This phase II trial is studying how well IMC-A12 works in treating patients with advanced liver cancer. Monoclonal antibodies, such as IMC-A12, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PRIMARY OBJECTIVES: I. To determine the progression-free survival (PFS) at 4 months in patients with advanced hepatocellular carcinoma (HCC) treated with anti-IGF-1R recombinant monoclonal antibody IMC-A12. II. To determine the best overall response rate in patients treated with this drug. SECONDARY OBJECTIVES: I. To determine the median overall survival of patients treated with this drug. II. To evaluate the safety, tolerability, and adverse events profile of this drug in these patients. III. To perform a subgroup analysis to compare PFS of patients with advanced HCC who are hepatitis B positive/hepatitis C negative versus patients who are hepatitis B negative/hepatitis C positive treated with this drug. IV. To store pre-therapy paraffin embedded tumor tissue for future tissue-based correlative studies. V. To evaluate tumor necrotic areas using a new volumetric method of assessing non-viable tumor as a correlate for response. VI. To prospectively validate and compare the CLIP and the GDETCH staging systems and additional prognostic factors. OUTLINE: Patients receive anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo serum sample collection at baseline for future tissue-based correlative studies. Previously collected paraffin embedded tumor tissue samples are also stored for future correlative studies. After completion of study treatment, patients are followed every 3 months for at least 1 year.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
Given IV
Undergo contrast-enhanced computed tomography
Undergo contrast-enhanced magnetic resonance imaging
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
PFS Rate
PFS defined as the time from first date of first treatment on the study until such time as progressive disease is confirmed or upon patient death if disease progression has not been evident at that time. A Simon's optimal two stage design will be used with the following assumption: a 4 months PFS of 62% is considered acceptable while a 4 months PFS of 42% is not acceptable.
Time frame: At 4 months
Best Overall Response Rate (ORR)
Best overall ORR will be defined as the proportion of patients achieving either confirmed partial response (PR) or confirmed complete response (CR). A Simon's optimal two stage design will be used with the following assumption: ORR of more than 20% is acceptable and an ORR less than 5% is not acceptable.
Time frame: From the start of the treatment until disease progression/recurrence
Median Overall Survival
Median Overall Survival
Time frame: Post-Treatment
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