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

• Status: Terminated
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene Corporation
• Treatments: Cetuximab; Lenalidomide; Thalidomide

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.