Lenalidomide and Cetuximab in Treating Patients With Metastatic Colorectal Cancer
- Conditions
- Colon CancerRectal Cancer
- Interventions
- Biological: cetuximabOther: mutation analysisOther: polymerase chain reactionGenetic: polymorphism analysis
- Registration Number
- NCT01126450
- Lead Sponsor
- Case Comprehensive Cancer Center
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm I cetuximab 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. Arm I mutation analysis 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. Arm I polymerase chain reaction 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. Arm I polymorphism analysis 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. Arm I 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.
- Primary Outcome Measures
Name Time Method Safety / Tolerability (type, frequency, severity, and relationship of adverse events to study drug) Courses repeat every 28 days in the absence of unacceptable toxicity.
- Secondary Outcome Measures
Name Time Method Time to progression of disease Courses repeat every 28 days in the absence of disease progression . Tumor response according to RECIST at the end of Cycle 2 and every 56 days thereafter until tumor progression Lab correlatives (FCGRIIa and FCGRIIIa polymorphisms, K-Ras and B-Raf mutations) Tissue collection less than or equal to 28 days prior to day 1 of therapy FCGR2a and FCGR3a polymorphisms, K-Ras and B-Raf mutations in patient specimens (paraffin embedded formaldehyde fixed tissues) will be identified.
Trial Locations
- Locations (1)
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States