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A Study to Assess the Efficacy and Safety of Lenalidomide in Combination With Cetuximab in Pre-treated Patients With KRAS Mutant Colorectal Cancer

This study has been terminated.
(A business decision not to continue with Phase 2b based on non-safety observations during proof of concept phase.)
Information provided by (Responsible Party):
Celgene ( Celgene Corporation ) Identifier:
First received: December 14, 2009
Last updated: April 1, 2013
Last verified: April 2013
The purpose of this study is to determine whether lenalidomide in combination with cetuximab is safe and effective in patients with KRAS mutant colorectal cancer.

Condition Intervention Phase
Colorectal Cancer
Drug: cetuximab
Drug: lenalidomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label Study To Evaluate The Efficacy And Safety Of Lenalidomide In Combination With Cetuximab In Pretreated Subjects With K-Ras Mutant Metastatic Colorectal Cancer

Resource links provided by NLM:

Further study details as provided by Celgene:

Primary Outcome Measures:
  • Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle of the Safety Lead-In Period [ Time Frame: Up to Day 28 (Cycle 1) ]

    The number of participants with DLTs determines the maximum tolerated dose of the combination therapy used in the Proof of Concept (POC) period:

    If <2 of the initial 6 participants experience a DLT, then the POC will start with lenalidomide at 25 mg.

    If ≥2 of the initial 6 participants experienced a DLT, then 6 more subjects were to be enrolled at 20 mg lenalidomide.

    If <2 of the additional 6 subjects experienced a DLT, then the lenalidomide starting dose for the POC was to be 20 mg.

    If ≥2 of the additional 6 subjects experienced a DLT, then 6 more subjects were to be enrolled at 15 mg lenalidomide.

    If <2 of the additional 6 subjects experienced a DLT, then the POC was to start with lenalidomide at 15 mg.

    If ≥2 of the additional 6 subjects experienced a DLT, the dosing for the study was to be reassessed by Celgene Corporation and the investigators.

  • Percentage of Participants With a Response to Treatment During the Proof of Concept Period [ Time Frame: week 9 up to week 24 ]

    Tumor response was evaluated every 2 cycles beginning with Cycle 3 Day 1 and at treatment discontinuation. Response and progression were evaluated using the RECIST 1.1 criteria (Eisenhauer, 2009).

    Treatment response includes both complete response and partial response.

    • Complete response-disappearance of all lesions
    • Partial response-30% decrease in the sum of diameters of target lesions from baseline

    Analysis was not performed due to the early termination of the study.

Secondary Outcome Measures:
  • Kaplan-Meier Estimates for Progression Free Survival (PFS) [ Time Frame: up to week 24 ]

    PFS was calculated as the time from randomization to the earlier of the first documentation of progressive disease (PD), or death on study due to any cause.

    Analysis was not performed due to the early termination of the study.

  • Kaplan-Meier Estimates for Duration of Response [ Time Frame: up to week 24 ]

    Duration of response was defined as the time from the initial response date to progressive disease (PD) for participants who achieved an objective confirmed complete response (CR) or partial response (PR).

    Analysis was not performed due to the early termination of the study.

  • Percentage of Participants With Disease Control [ Time Frame: up to week 24 ]

    Known as the Disease Control Rate (DCR), participants with a complete response, partial response or stable disease contribute to the DCR.

    This analysis was not performed due to the early termination of the study.

  • Kaplan-Meier Estimates for Overall Survival [ Time Frame: up to 5.5 years ]

    Overall survival was defined as the time between randomization and death. It was intended that participants would be followed for up to 5 years following discontinuation from treatment.

    Analysis was not performed due to the early termination of the study.

  • Participants With Treatment-Emergent Adverse Events (TEAE) [ Time Frame: up to week 28 ]
    TEAEs are any adverse event occurring or worsening on or after the first treatment of any study drug and within 28 days after the last dose of the last study drug received. Relation to study drug was determined by the investigator. Severity of AE is graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.0. Severity is a 5-point scale: 3= severe or medically significant but not life-threatening 4=life-threatening, urgent intervention required 5=death related to AE.

Enrollment: 51
Study Start Date: December 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lenalidomide plus cetuximab
Combination therapy of lenalidomide plus cetuximab
Drug: cetuximab
Intravenous infusions of cetuximab (400 mg/m^2 Cycle 1 Day 1, thereafter 250 mg/m^2), administered on days 1, 8, 15 and 22 of each 28 day cycle.
Other Name: Erbitux
Drug: lenalidomide
Daily oral lenalidomide 25mg on days 1 to 28 of each 28 day cycle
Other Name: Revlimid
Experimental: lenalidomide
Single agent therapy of lenalidomide
Drug: lenalidomide
Daily oral lenalidomide 25mg on days 1 to 28 of each 28 day cycle
Other Name: Revlimid


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

Inclusion Criteria:

  1. Metastatic colorectal adenocarcinoma.
  2. Confirmed K-RAS mutant tumor
  3. Disease progression on oxaliplatin- AND irinotecan-containing regimens, with at least one of these regimens containing bevacizumab.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.

Exclusion Criteria:

  1. Use of chemotherapy, hormonal therapy, immunotherapy or any other cancer or experimental treatment ≤ 28 days prior to the first day of the first cycle.
  2. Radiotherapy for up to ≥ 30% of the bone marrow.
  3. Surgery ≤ 28 days before day 1 of the first cycle (minimally invasive interventions for diagnostic purposes or disease staging are permitted).
  4. Previous treatment with cetuximab, panitumumab, pomalidomide (CC-4047), lenalidomide or thalidomide.
  5. Untreated, symptomatic brain metastases (brain imaging not required).
  6. Venous thromboembolism ≤ 6 months before day1 of the first cycle.
  7. Current congestive heart failure (classes II to IV of the New York Heart Association).
  8. Myocardial infarction ≤ 12 months before day1 of the first cycle.
  9. Uncontrolled hypertension.
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Please refer to this study by its identifier: NCT01032291

Australia, South Australia
Flinders Medical Centre, Dept. of Oncology
Bedford Park, South Australia, Australia
UZ Antwerpen Dept. of Medical Oncology
Antwerp, Belgium
ULB Erasme Service de Gastroenterologie
Brussels, Belgium
Grand hôpital de Charleroi, Oncologie
Charleroi, Belgium
Algemeen Ziekenhuis Maria Middelares
Gent, Belgium
Universitaire Ziekenhuis Gasthuisberg K.U. Leuven Gastroenterologie, Oncologie
Leuven, Belgium
Centre Hospitalier Universitaire Sart Tilman Liège
Liège, Belgium
Klinikum Oldenburg gGmbH Klinik für Innere Medizin II
Oldenburg, Niedersachsen, Germany
Azienda Osperdaliero Universitaria Riuniti Umberto I-GM Lancisi-G. Salesi di Ancona Clinica di Oncologia Medica
Ancona, Italy
Azienda Ospedaliera Universitaria San Martino Unità Operativa Oncologia Medica
Genova, Italy
Azienda Ospedaliera Niguarda Ca' Grande, Oncologia Medica Falck
Milano, Italy
Hospital Vall D'Hebron Servicio de Oncología. Unidad de ensayos clínicos
Barcelona, Spain
Hospital Universitario Marques de Valdecilla Servicio de Oncología
Santander, Spain
Hospital Clinico Universitario de Valencia Servicio de Oncologia
Valencia, Spain
Östra Sjukhuset Kirurgkliniken
Gothenburg, Sweden
Karolinska University Hospital, Solna, Karolinska Institutet Dept of Oncology
Stockholm, Sweden
Akademiska Sjukhuset Onkologkliniken
Uppsala, Sweden
Sponsors and Collaborators
Celgene Corporation
Principal Investigator: Eric Van Cutsem, M.D., Ph,D Universitaire Ziekenhuis Gasthuisberg K.U. Leuven, Belgium
Principal Investigator: Josep Tabernero, M.D. Hospital Vall d´Hebrón, Servicio de Oncología, Barcelona. Spain
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Celgene Corporation Identifier: NCT01032291     History of Changes
Other Study ID Numbers: CC-5013-COLO-001
2009-012665-61 ( EudraCT Number )
Study First Received: December 14, 2009
Results First Received: April 1, 2013
Last Updated: April 1, 2013

Keywords provided by Celgene:
Colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents processed this record on May 25, 2017