A Phase 2 Study of EZN-2208 (PEG-SN38) Administered With or Without Cetuximab in Patients With Metastatic Colorectal Carcinoma (mCRC)
This is a Phase 2, multicenter, multiple-arm, open-label study to evaluate the efficacy, safety, and tolerability of EZN-2208. EZN-2208 will be administered as a single agent in patients with K-RAS mutations in the tumors. Patients with wild type K-RAS in tumors will be randomized to EZN-2208 + cetuximab or to standard of care (CamptosarŽ + cetuximab), patients must have failed regimens containing irinotecan (CamptosarŽ, CPT-11), oxaliplatin (EloxatinŽ), and fluoropyrimidine. After discontinuation of study treatment, patients will receive care as considered appropriate by the investigator. Patients will continue to be followed for disease progression, subsequent anticancer therapy, and survival.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : EZN-2208, Cetuximab and Irinotecan
Phase: Phase 2
Ages Eligible For Study:
- Patients must meet all of the following criteria to be eligible for enrollment in the study. 1. Histologically confirmed CRC adenocarcinoma that is metastatic or locally recurrent CRC that is nonresectable 2. Patients must agree to genetic testing of the original or metastatic CRC tumor biopsy tissue for K-RAS mutational status. 3. Disease progression 4. Previous therapy with irinotecan, oxaliplatin, and fluoropyrimidine either alone or in any combination(s). Patients must have radiographically documented progressive disease while receiving, or within 3 months of receiving, these agents alone or in combination. 5. No more than 2 prior cytotoxic chemotherapy regimens. 6. Age 18 years or older 7. Measurable disease by RECIST Version 1.1 8. ECOG performance status of 0 or 1 9. Adequate bone marrow, renal, and hepatic function