NCT01126450

Lenalidomide and Cetuximab in Treating Patients With Metastatic Colorectal Cancer

A Phase I, Open-Label Study To Determine The Maximum Tolerated Dose (Mtd) Of The Combination Of Lenalidomide And Cetuximab, And To Evaluate The Efficacy Of This Combination In Subjects With Wild Type K-Ras Metastatic Colorectal Carcinoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Lenalidomide may stop the growth of tumor cells by blocking blood flow to the tumor. Monoclonal antibodies, such as cetuximab, 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. Giving lenalidomide together with cetuximab may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide when given together with cetuximab in treating patients with metastatic colorectal cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD). SECONDARY OBJECTIVES: I. To further explore the safety and efficacy profile. OUTLINE: This is a dose-escalation study of lenalidomide. Patients receive oral lenalidomide once daily on days 1-28 and cetuximab IV once weekly over 1-2 hours on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.

Conditions

• Colon Cancer
• Rectal Cancer

Interventions

Type	Name	Description
DRUG	lenalidomide	Given orally
BIOLOGICAL	cetuximab	Given IV
OTHER	mutation analysis	Correlative studies
OTHER	polymerase chain reaction	Correlative studies
GENETIC	polymorphism analysis	Correlative studies

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-11-01
• Completion: 2010-12-01
• First posted: 2010-05-19
• Last updated: 2012-03-20

Locations

1 site across 1 country: United States