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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
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Start Date
October 1, 2009
Primary Completion Date
November 1, 2010
Completion Date
December 1, 2010
Last Updated
March 20, 2012
3
ACTUAL participants
lenalidomide
DRUG
cetuximab
BIOLOGICAL
mutation analysis
OTHER
polymerase chain reaction
OTHER
polymorphism analysis
GENETIC
Lead Sponsor
Case Comprehensive Cancer Center
NCT04704661
NCT04929028
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