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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
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.
Daily oral lenalidomide 25mg on days 1 to 28 of each 28 day cycle
Flinders Medical Centre, Dept. of Oncology
Bedford Park, South Australia, Australia
UZ Antwerpen Dept. of Medical Oncology
Antwerp, Belgium
Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle of the Safety Lead-In Period
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.
Time frame: Up to Day 28 (Cycle 1)
Percentage of Participants With a Response to Treatment During the Proof of Concept Period
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.
Time frame: week 9 up to week 24
Kaplan-Meier Estimates for Progression Free Survival (PFS)
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.
Time frame: up to week 24
Kaplan-Meier Estimates for Duration of Response
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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
...and 7 more locations
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.
Time frame: up to week 24
Percentage of Participants With Disease Control
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.
Time frame: up to week 24
Kaplan-Meier Estimates for Overall Survival
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.
Time frame: up to 5.5 years
Participants With Treatment-Emergent Adverse Events (TEAE)
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.
Time frame: up to week 28