A Study of EZN-2208 Administered With or Without Cetuximab in Patients With Metastatic Colorectal Carcinoma
Metastatic Colorectal Cancer
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring EZN-2208 (PEG-SN38)
Eligibility Criteria
Inclusion Criteria:
Patients must meet all of the following criteria to be eligible for enrollment in the study.
- Histologically confirmed CRC adenocarcinoma that is metastatic or locally recurrent CRC that is nonresectable
- Patients must agree to genetic testing of the original or metastatic CRC tumor biopsy tissue for K-RAS mutational status.
- Disease progression
- 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.
- No more than 2 prior cytotoxic chemotherapy regimens.
- Age 18 years or older
- Measurable disease by RECIST Version 1.1
- ECOG performance status of 0 or 1
- Adequate bone marrow, renal, and hepatic function
Exclusion Criteria:
Patients meeting any of the following exclusion criteria will not be eligible for enrollment.
- Known chronic infectious disease
- Major surgery within 3 weeks before study start
- Known or suspected brain metastases requiring intervention with steroids and/or radiation therapy.
- Prior chemotherapy, immunotherapy, non-investigational agent, or other therapy used to treat the cancer within 3 weeks before the scheduled administration of EZN-2208
History of other primary cancer within 5 years of enrollment, unless
- Curatively resected non-melanomatous skin cancer, or
- Curatively resected cervical cancer
- Lack of recovery to Grade 1 from any reversible side effects related to the administration of an investigational agent, or other prior treatments for the cancer
- Any condition such as uncontrollable diabetes, uncontrollable hypertension, or active infection.
- Current participation in another clinical study with an investigational agent and/or use of an investigational drug (not including investigational use of an approved drug) in the 30 days before the first administration of EZN-2208
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
EZN-2208
Cetuximab + EZN-2208
Irinotecan + cetuximab
EZN-2208 will be administered as an i.v. infusion on weekly basis for 3 weeks and repeated every 28 days. PLEASE NOTE THAT ENROLLMENT IN EXPERIMENTAL ARM (ARM A) IS COMPLETE. NO NEW PATIENT IN THIS ARM IS ALLOWED TO ENROLL.
Cetuximab will be administered as an i.v. infusion on weekly basis. EZN-2208 administered as i.v. infusion on weekly basis for 3 weeks and repeated every 28 days.
Cetuximab will be administered weekly as an i.v. infusion. Irinotecan will be administered as an i.v. infusion on Weeks 1 and 2 and repeated every 3 weeks.