Clinical trial NCT01032291: A Study to Assess the Efficacy and Safety of Lenalidomide in Combination With Cetuximab in Pre-treated Patients With KRAS Mutant Colorectal Cancer
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: Colorectal cancer
Revlimid
Lenalidomide
Cetuximab
Erbitux
KRAS
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2009-12-15
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Participants With Dose Limiting Toxicities (DLTs) During the First Treatment Cycle of the Safety Lead-In Period
timeFrame: Up to Day 28 (Cycle 1)
measure: Percentage of Participants With a Response to Treatment During the Proof of Concept Period
timeFrame: week 9 up to week 24
Secondary outcomes:
measure: Kaplan-Meier Estimates for Progression Free Survival (PFS)
timeFrame: up to week 24
measure: Kaplan-Meier Estimates for Duration of Response
timeFrame: up to week 24
measure: Percentage of Participants With Disease Control
timeFrame: up to week 24
measure: Kaplan-Meier Estimates for Overall Survival
timeFrame: up to 5.5 years
measure: Participants With Treatment-Emergent Adverse Events (TEAE)
timeFrame: up to week 28
Other outcomes:
Locations:
city: Bedford Park
country: Australia
facility: Flinders Medical Centre, Dept. of Oncology
state: South Australia
city: Antwerp
country: Belgium
facility: UZ Antwerpen Dept. of Medical Oncology
city: Brussels
country: Belgium
facility: ULB Erasme Service de Gastroenterologie
city: Charleroi
country: Belgium
facility: Grand hôpital de Charleroi, Oncologie
city: Gent
country: Belgium
facility: Algemeen Ziekenhuis Maria Middelares
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuis Gasthuisberg K.U. Leuven Gastroenterologie, Oncologie
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire Sart Tilman Liège
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg gGmbH Klinik für Innere Medizin II
state: Niedersachsen
city: Ancona
country: Italy
facility: Azienda Osperdaliero Universitaria Riuniti Umberto I-GM Lancisi-G. Salesi di Ancona Clinica di Oncologia Medica
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria San Martino Unità Operativa Oncologia Medica
city: Milano
country: Italy
facility: Azienda Ospedaliera Niguarda Ca' Grande, Oncologia Medica Falck
city: Barcelona
country: Spain
facility: Hospital Vall D'Hebron Servicio de Oncología. Unidad de ensayos clínicos
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla Servicio de Oncología
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia Servicio de Oncologia
city: Gothenburg
country: Sweden
facility: Östra Sjukhuset Kirurgkliniken
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Solna, Karolinska Institutet Dept of Oncology
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset Onkologkliniken
Study officials:
affiliation: Universitaire Ziekenhuis Gasthuisberg K.U. Leuven, Belgium
name: Eric Van Cutsem, M.D., Ph,D
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Vall d´Hebrón, Servicio de Oncología, Barcelona. Spain
name: Josep Tabernero, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.