A Study to Assess the Efficacy and Safety of Lenalidomide in Combination With Cetuximab in Pre-treated Patients With KRAS Mutant Colorectal Cancer
NCT ID: NCT01032291
Last Updated: 2013-05-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
51 participants
INTERVENTIONAL
2009-12-31
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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lenalidomide plus cetuximab
Combination therapy of lenalidomide plus cetuximab
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.
lenalidomide
Daily oral lenalidomide 25mg on days 1 to 28 of each 28 day cycle
lenalidomide
Single agent therapy of lenalidomide
lenalidomide
Daily oral lenalidomide 25mg on days 1 to 28 of each 28 day cycle
Interventions
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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.
lenalidomide
Daily oral lenalidomide 25mg on days 1 to 28 of each 28 day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Celgene Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Eric Van Cutsem, M.D., Ph,D
Role: PRINCIPAL_INVESTIGATOR
Universitaire Ziekenhuis Gasthuisberg K.U. Leuven, Belgium
Josep Tabernero, M.D.
Role: PRINCIPAL_INVESTIGATOR
Hospital Vall d´Hebrón, Servicio de Oncología, Barcelona. Spain
Locations
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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
Ghent, , 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, Lower Saxony, 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
Milan, , 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
Countries
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References
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Gandhi AK, Shi T, Li M, Jungnelius U, Romano A, Tabernero J, Siena S, Schafer PH, Chopra R. Immunomodulatory effects in a phase II study of lenalidomide combined with cetuximab in refractory KRAS-mutant metastatic colorectal cancer patients. PLoS One. 2013 Nov 11;8(11):e80437. doi: 10.1371/journal.pone.0080437. eCollection 2013.
Siena S, Van Cutsem E, Li M, Jungnelius U, Romano A, Beck R, Bencardino K, Elez ME, Prenen H, Sanchis M, Sartore-Bianchi A, Tejpar S, Gandhi A, Shi T, Tabernero J. Phase II open-label study to assess efficacy and safety of lenalidomide in combination with cetuximab in KRAS-mutant metastatic colorectal cancer. PLoS One. 2013 Nov 11;8(11):e62264. doi: 10.1371/journal.pone.0062264. eCollection 2013.
Other Identifiers
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2009-012665-61
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CC-5013-COLO-001
Identifier Type: -
Identifier Source: org_study_id
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