NCT00639509

IMC-A12 in Treating Patients With Advanced Liver Cancer

A Phase 2 Study of IMC-A12 (NSC742460) in Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Adult Primary Hepatocellular Carcinoma
• Advanced Adult Primary Liver Cancer
• Localized Unresectable Adult Primary Liver Cancer
• Recurrent Adult Primary Liver Cancer

Interventions

Type	Name	Description
BIOLOGICAL	cixutumumab	Given IV
PROCEDURE	computed tomography	Undergo contrast-enhanced computed tomography
PROCEDURE	contrast-enhanced magnetic resonance imaging	Undergo contrast-enhanced magnetic resonance imaging

Timeline

• Start date: 2008-03-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2008-03-20
• Last updated: 2014-05-23
• Results posted: 2013-12-03

Locations

1 site across 1 country: United States