Lenalidomide and Cetuximab in Treating Patients With Metastatic Colorectal Cancer

NCT01126450 | Terminated Phase 1 DMC

• 2 other identifiers: CASE8208NCI-2010-01202
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer; Rectal Cancer

Keywords

recurrent colon cancer; recurrent rectal cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

Arm I

EXPERIMENTAL

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; Biological: cetuximab; Other: mutation analysis; Other: polymerase chain reaction; Genetic: polymorphism analysis

Interventions

lenalidomide DRUG

Given orally

Also known as: CC-5013, IMiD-1, Revlimid

Arm I

cetuximab BIOLOGICAL

Given IV

Also known as: Anti-EGFR Monoclonal Antibody, C225, C225 monoclonal antibody, IMC-C225, MOAB C225, monoclonal antibody C225

Arm I

mutation analysis OTHER

Correlative studies

Arm I

polymerase chain reaction OTHER

Correlative studies

Also known as: PCR

Arm I

polymorphism analysis GENETIC

Correlative studies

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Interventions

Lenalidomide; Cetuximab; Polymerase Chain Reaction; Amplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques; DNA Fingerprinting

Study Officials

• Richard Kim

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2010
• First Posted: May 19, 2010
• Study Start: October 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 20, 2012

Record last verified: 2012-03

Locations

US (1)