Lenalidomide and Cetuximab in Treating Patients With Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01126450
Recruitment Status : Terminated (low accrual,loss of funding and results from EU study showing drug ineffective.)
First Posted : May 19, 2010
Last Update Posted : March 20, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Colon Cancer Rectal Cancer Drug: lenalidomide Biological: cetuximab Other: mutation analysis Other: polymerase chain reaction Genetic: polymorphism analysis Phase 1

Detailed Description:


I. To determine the maximum tolerated dose (MTD).


I. To further explore the safety and efficacy profile.


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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm I
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.
Drug: lenalidomide
Given orally
Other Names:
  • CC-5013
  • IMiD-1
  • Revlimid
Biological: cetuximab
Given IV
Other Names:
  • Anti-EGFR Monoclonal Antibody
  • C225
  • C225 monoclonal antibody
  • IMC-C225
  • MOAB C225
  • monoclonal antibody C225
Other: mutation analysis
Correlative studies
Other: polymerase chain reaction
Correlative studies
Other Name: PCR
Genetic: polymorphism analysis
Correlative studies

Primary Outcome Measures :
  1. Safety / Tolerability (type, frequency, severity, and relationship of adverse events to study drug) [ Time Frame: Courses repeat every 28 days in the absence of unacceptable toxicity. ]

Secondary Outcome Measures :
  1. Time to progression of disease [ Time Frame: Courses repeat every 28 days in the absence of disease progression . ]
  2. Tumor response according to RECIST [ Time Frame: at the end of Cycle 2 and every 56 days thereafter until tumor progression ]
  3. Lab correlatives (FCGRIIa and FCGRIIIa polymorphisms, K-Ras and B-Raf mutations) [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Wild type metastatic colorectal cancer that failed (progressed, refused or not tolerated) on at least two treatment regimens including a fluoropyrimidine, oxaliplatin and irinotecan with or without bevacizumab
  • At least 28 days must have lapsed since completion of prior chemotherapy
  • Subjects must understand and voluntarily sign an informed consent document
  • Subjects must be able to adhere to the study visit schedule and other protocol requirements
  • Histological or cytological diagnosis of colorectal carcinoma
  • Radiographic or clinical evidence of a measurable disease (by RECIST criteria)
  • Subjects must have received prior treatment with at least 2 prior regimens of therapy
  • ECOG performance status of =< 1
  • Anticipated survival >= 3 months
  • Must agree to also take low dose aspirin (or other anticoagulation if unable to take ASA) while receiving study drug and for 30 days after study drug is discontinued
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test within 10-14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing
  • Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy


  • Pregnant or lactating females
  • CrCl < 50 mL/min by Cock-Croft and Gault
  • Any serious medical condition or psychiatric illness that places the subject at an unacceptable risk for study participation or would prevent the subject from signing the informed consent
  • Use of any cytotoxic chemotherapy within 28 days of study Day 1
  • Use of therapeutic radiation =< 14 days prior to study Day 1
  • Use of thalidomide, or structurally related compounds or biologic response modifier therapy within 14 days of study Day 1
  • Prior desquamating rash while taking thalidomide, or structurally related compound therapy
  • Prior >= Grade 2 allergic reaction to thalidomide or structurally related compounds
  • Any prior use of Lenalidomide
  • Subjects may have received prior thalidomide
  • Known or suspected brain metastases
  • Concurrent use or anticipated use of any other anti-cancer agents (except for stable dose steroid use for control of metastases symptoms) during participation in this study
  • Absolute Neutrophil Count =< 1500/mm^3 (or 1.5 X10^9/L)
  • Platelet Count =< 100,000/mm^3 (or 100 X 10^9/L)
  • Hemoglobin < 8.0 g/dL
  • Total Bilirubin > 2.0mg/dL
  • Alanine Aminotransferase (ALT/SGPT) >= 3 x upper limit of normal (ULN)
  • Aspartate Aminotransferase (AST/SGOT) >= 3 x upper limit of normal (ULN)
  • Peripheral neuropathy >= Grade 2
  • Active infection
  • Subjects with an infection that is amenable to curative treatment may be eligible for screening once the infection has been treated, cured and not recurred for at least 14 days
  • Uncontrolled hyper- or hypo- calcemia, glycosemia or thyroidism
  • Arterial or venous thrombotic event in the preceding six months
  • Known history of HIV infection
  • Active viral hepatitis who is on active treatment
  • No other malignancies, other than previously treated non-melanoma skin cancer or carcinoma insitu of the cervix or breast

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01126450

United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
Principal Investigator: Richard Kim Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Responsible Party: Case Comprehensive Cancer Center Identifier: NCT01126450     History of Changes
Other Study ID Numbers: CASE8208
NCI-2010-01202 ( Other Identifier: National Cancer Institute )
CASE8208 ( Other Identifier: Case Comprehensive Cancer Center )
First Posted: May 19, 2010    Key Record Dates
Last Update Posted: March 20, 2012
Last Verified: March 2012

Keywords provided by Case Comprehensive Cancer Center:
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Rectal Neoplasms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents