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

Celgene

Status and phase: Terminated; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: lenalidomide; Drug: cetuximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01032291

2009-012665-61 (EudraCT Number)

CC-5013-COLO-001

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

lenalidomide plus cetuximab

Experimental group

Description:

Combination therapy of lenalidomide plus cetuximab

Treatment:

Drug: lenalidomide

Drug: cetuximab

lenalidomide

Experimental group

Description:

Single agent therapy of lenalidomide

Treatment:

Drug: lenalidomide