MK-2206 and AZD6244 in Patients With Advanced Colorectal Carcinoma
Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
Summary
Background:
- MK-2206 and AZD6244 (Selumetinib) are experimental cancer treatment drugs that block the
effect of certain proteins that cancer cells need to grow and survive. These drugs may be
effective treatments for some types of colorectal cancer that has not responded to or has
relapsed after standard treatment. Researchers are interested in studying how MK-2206 and
AZD6244 affect levels of certain proteins in colorectal cancer tumor, and how well the drugs
work against cancer cells by examining cells from a tumor sample collected before the drugs
are given and again after the drugs are given.
Objectives:
- To evaluate the safety and effectiveness of MK-2206 and AZD6244 in individuals with
advanced colorectal carcinoma that has not responded to standard treatments.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with advanced colorectal
carcinoma that has not responded to at least one type of standard chemotherapy.
Design:
- Participants will be screened with a physical examination, medical history, blood tests,
and tumor imaging studies.
- Participants will take MK-2206 and AZD6244 by mouth for 4-week cycles of treatment, with
one dose of MK-2206 per week and one dose of AZD6244 every day. (If participants have
negative side effects from the medications, the doses will be adjusted to a smaller
dose). Participants will keep a diary to record doses and keep track of any side
effects.
- During treatment, participants will have regular visits to the clinical center,
involving blood and urine tests, tumor biopsies, and other examinations to monitor the
effects of treatment. Participants will have imaging studies every two cycles (8 weeks)
to study the cancer's response to the treatment.
- Participants will continue to have cycles of treatment for as long as the treatment
continues to be effective and the side effects are not severe enough to stop
participation in the study....