Phase 1 Study of the Combination of 1018 ISS, Irinotecan and Cetuximab in Patients With Metastatic Colorectal Cancer Previously Treated With a Fluoropyrimidine, Oxaliplatin or Irinotecan With or Without Bevacizumab
This is a Phase I, open-label study of escalating dose levels of 1018 ISS in combination
with irinotecan and cetuximab in patients with previously treated metastatic colorectal
cancer. Approximately 15 patients will be treated. The objectives of this study are to
establish a safe, tolerable, and active dose of 1018 ISS, determine tumor response, time to
disease progression, and overall survival in treated patients.
The safety and tolerability of 1018 ISS will be evaluated by periodic laboratory
assessments, physical examinations, and compilation of adverse events.
Once study patients have been consented, screened, and assigned to one of the dose levels of
1018 ISS, patients will receive two 4 week cycles of 1018 ISS therapy plus irinotecan every
other week and cetuximab weekly. Irinotecan and cetuximab will continue thereafter until
disease progression, unacceptable toxicity, or until the patient refuses treatment.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Occurrence of adverse events
Eduardo Martins, MD, DPhil
Dynavax Technologies Corporation
United States: Food and Drug Administration
|Center for Cancer and Blood Disorders||Bethesda, Maryland 20817|
|Premiere Oncology||Santa Monica, California 90404|
|Lombardi Comprehensive Cancer Center, Georgetown University||Washington, District of Columbia 20007|