A Study to Assess the Efficacy and Safety of Lenalidomide in Combination With Cetuximab in Pre-treated Patients With KRAS Mutant Colorectal Cancer
Information source: Celgene Corporation
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colorectal Cancer
Intervention: cetuximab (Drug); lenalidomide (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Celgene Corporation Official(s) and/or principal investigator(s): Eric Van Cutsem, M.D., Ph,D, Principal Investigator, Affiliation: Universitaire Ziekenhuis Gasthuisberg K.U. Leuven, Belgium Josep Tabernero, M.D., Principal Investigator, Affiliation: Hospital Vall d´Hebrón, Servicio de Oncología, Barcelona. Spain
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle of the Safety Lead-In PeriodPercentage of Participants With a Response to Treatment During the Proof of Concept Period
Secondary outcome: Kaplan-Meier Estimates for Progression Free Survival (PFS)Kaplan-Meier Estimates for Duration of Response Percentage of Participants With Disease Control Kaplan-Meier Estimates for Overall Survival Participants With Treatment-Emergent Adverse Events (TEAE)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
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
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
Klinikum Oldenburg gGmbH Klinik für Innere Medizin II, Oldenburg, Niedersachsen, Germany
Flinders Medical Centre, Dept. of Oncology, Bedford Park, South Australia, Australia
Additional Information
Starting date: December 2009
Last updated: April 1, 2013
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