Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring KRN330, Colorectal Cancer, Antimetabolites, Antimetabolites, Antineoplastic, Digestive System Neoplasms, Immunologic Factors, Molecular Mechanisms of Pharmacological Action, Antineoplastic Agents, Gastrointestinal Diseases, Physiological Effects of Drugs, Colonic Diseases, Irinotecan, Enzyme Inhibitors, Intestinal Diseases, Immunosuppressive Agents, Rectal Diseases, Pharmacologic Actions, Intestinal Neoplasms, Neoplasms by Site, Digestive System Diseases, Therapeutic Uses, Fluorouracil, Neoplasms, Gastrointestinal Neoplasms, Antineoplastic Agents, Phytogenic, Colorectal Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Have histologically confirmed colorectal cancer that is metastatic with measurable disease.
- For the Phase II portion: Have recurred or progressed within 6 months of the last cycle of FOLFOX +/- bevacizumab first-line or adjuvant regimen for metastatic colorectal cancer. Note: Those who had initiated FOLFOX/CapOx but stopped oxaliplatin because of intolerable toxicity are also eligible.
- At least 4 weeks have elapsed since the last chemotherapy, radiotherapy, immunotherapy, or biologic therapy prior to enrollment (except at least 6 weeks in the case of nitrosourea and mitomycin).
- Have not received any other investigational agents within 4 weeks of study entry and have fully recovered from any adverse event due to prior therapy.
- At least 4 weeks have elapsed since any major surgery.
- Have ECOG performance status of 0, 1, or 2.
- Have adequate bone marrow and organ function
Exclusion Criteria:
- Have an active, uncontrolled infection.
- Have known HIV positive status.
- Have known or suspected cerebral metastasis.
- Have had a myocardial infarction (MI) or cerebrovascular accident (CVA) within the last 6 months; or meet the criteria for AHA class III or IV congestive heart failure (CHF).
- Have a medical condition requiring chronic use of high-dose corticosteroids or other chronic immunosuppressive therapy (e.g. methotrexate, azathioprine).
- Have a history of greater than or equal to Grade 2 allergic reaction or hypersensitivity following exposure to humanized or human monoclonal antibodies (but not chimeric antibodies).
- Pregnant or breastfeeding women and male or female patients who do not agree to use effective contraceptive method(s) during the study.
Sites / Locations
- Clearview Cancer Institute
- Arizona Clinical Research Center
- USC/Norris Comprehensive Cancer Center
- Lombardi Comprehensive Cancer Center, Georgetown University Hospital
- Florida Cancer Specialists
- University of Florida COllege of Medicine/Shands Cancer Center
- University of Miami - Sylvester Comprehensive Cancer Center
- Emory University - Winship Cancer Institute
- Greater Baltimore Medical Center
- NYU Clinical Trials Office, New York University Cancer Institute
- Sarah Cannon Research Institute
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Experimental
KRN330 + Irinotecan
open label, single arm