IMC-A12 in Treating Patients With Advanced Liver Cancer
|Adult Primary Hepatocellular Carcinoma Advanced Adult Primary Liver Cancer Localized Unresectable Adult Primary Liver Cancer Recurrent Adult Primary Liver Cancer||Biological: cixutumumab Procedure: computed tomography Procedure: contrast-enhanced magnetic resonance imaging||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of IMC-A12 (NSC742460) in Hepatocellular Carcinoma|
- PFS Rate [ Time Frame: At 4 months ]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.
- Best Overall Response Rate (ORR) [ Time Frame: From the start of the treatment until disease progression/recurrence ]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.
- Median Overall Survival [ Time Frame: Post-Treatment ]Median Overall Survival
|Study Start Date:||March 2008|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Experimental: Treatment (monoclonal antibody therapy)
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.
Other Names:Procedure: computed tomography
Undergo contrast-enhanced computed tomography
Other Name: tomography, computedProcedure: contrast-enhanced magnetic resonance imaging
Undergo contrast-enhanced magnetic resonance imaging
Other Name: Contrast-enhanced MRI
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639509
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Ghassan Abou-Alfa||Memorial Sloan Kettering Cancer Center|