EZN-2208 (Pegylated SN-38) in Combination With Bevacizumab in Refractory Solid Tumors
Status:
Completed
Trial end date:
2014-04-23
Target enrollment:
Participant gender:
Summary
Background:
- The anticancer drug bevacizumab works by reducing the formation of new blood vessels in
tumors, which can slow or stop the growth of cancer cells and supporting blood vessels. The
experimental drug EZN-2208 works by limiting how well cancer cells can divide. Drugs similar
to EZN-2208 also work by turning off the production of the HIF protein, which otherwise can
help cancer cells to grow even when blood supply is limited. Researchers are interested in
determining if EZN-2208 turns off HIF in patient tumors, and whether combining it with
bevacizumab is an effective treatment for cancers that have not responded to standard
treatment.
Objectives:
- To assess the safety and effectiveness of the combination of EZN-2208 and bevacizumab for
solid tumors that have not responded to standard treatment.
Eligibility:
- Individuals at least 18 years of age who have solid tumors that have not responded to
standard treatment.
Design:
- Participants will be screened with a full physical examination and medical history,
blood and urine samples, and tumor imaging studies.
- Participants will receive EZN-2208 and bevacizumab intravenously on an outpatient basis
in 4-week cycles (with the exception of the first cycle, which will be 5 weeks).
- Cycle 1: Participants will receive EZN-2208 once a week for 3 weeks in a row (days 1, 8,
and 15), followed by 1 week without the drug. Participants will receive bevacizumab 1
week before EZN-2208 (day - 7) and then 3 weeks later (day 15).
- Subsequent cycles: Participants will receive EZN-2208 once a week for 3 weeks in a row
(days 1, 8, and 15), followed by 1 week without the drug. Participants will receive
bevacizumab every 2 weeks (days 1 and 15).
- Participants will have clinic visits with physical examinations and blood tests in the
first 3 weeks of each cycle. Clinic visits may also include tumor imaging studies and
tumor biopsies as directed by the study researchers.
- Participants will continue to take the study drugs for as long as the tumor shrinks or
does not grow, and as long as they do not experience intolerable or unsafe side effects
from the drugs.