NCT01008566

Cixutumumab and Sorafenib Tosylate in Treating Patients With Advanced Liver Cancer

A Phase I Trial of Escalating Doses of the Anti-IGF-1R Monoclonal Antibody IMC-A12 and Standard Dose Sorafenib for Treatment of Advanced Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial is studying the side effects and best dose of cixutumumab when given together with sorafenib tosylate in treating patients with advanced liver cancer. Monoclonal antibodies, such as cixutumumab, 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. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab together with sorafenib tosylate may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To establish the maximum tolerated dose (MTD) of IMC-A12 given in conjunction with standard doses of sorafenib to patients with advanced hepatocellular carcinoma (HCC). II. To describe the toxicity and tolerance of IMC-A12 at each dose studied in combination with standard-dose sorafenib in patients with advanced HCC. III. To evaluate the impact of IMC-A12 on biomarkers related to the IGF-1R/IGF pathway which is thought relevant to HCC progression and drug resistance. IV. To obtain preliminary assessments of efficacy through description of progression-free survival (PFS) and objective response rate (RR). OUTLINE: This is a multicenter, dose-escalation study of cixutumumab followed by an extended accrual phase in which patients are treated at the maximum-tolerated dose. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22 and oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up periodically.

Conditions

• Adult Hepatocellular Carcinoma
• Advanced Adult Hepatocellular Carcinoma
• Localized Non-Resectable Adult Liver Carcinoma
• Recurrent Adult Liver Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Cixutumumab	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Sorafenib Tosylate	Given orally

Timeline

• Start date: 2009-08-01
• Primary completion: 2016-05-01
• First posted: 2009-11-06
• Last updated: 2016-05-12

Locations

6 sites across 1 country: United States